Across 43 randomized trials and 10,361 thyroidectomy patients, the ultrasonic “harmonic” scalpel shortened mean operative time by 27.62 minutes compared with clamp-and-tie ligation (Cirocchi et al., International Journal of Surgery 2024). The same device, a blade vibrating at about 55.5 kHz, reached a peak of 234.5 °C on swine tissue right after it was switched off (Kim et al., Surgical Endoscopy 2008). And the US FDA’s adverse event database holds 54,179 reports carrying the Harmonic brand name, almost all of them device malfunctions (openFDA device adverse event endpoint, MAUDE data updated October 2026). We aggregated data from Cochrane, the International Journal of Surgery, Surgical Endoscopy, the FDA 510(k) and MAUDE databases, BMC Surgery, and more than a dozen other peer-reviewed meta-analyses and bench studies. This roundup covers ultrasonic cutting and coagulation in the operating room; for focused ultrasound that ablates tissue from outside the body, see our high-intensity focused ultrasound statistics. Nothing here is medical advice: the figures describe what trials, reviews and registries reported, with their limitations.
TL;DR
- Harmonic Scalpel blade frequency: 55.5 kHz, with 60 to 100 µm of blade travel (Sankaranarayanan et al., Surgical Endoscopy 2013).
- Harmonic ACE mean peak temperature on peritoneum: 195.9 °C, vs 96.4 °C for LigaSure V (Kim et al., Surgical Endoscopy 2008).
- Median burst pressure of 5-7 mm arteries sealed by Harmonic 7: 1,419 mmHg vs 591 mmHg for LigaSure, in a manufacturer-authored bench test (Timm et al., Medical Devices 2014).
- Thyroidectomy: mean operative time 27.62 minutes shorter with the FOCUS harmonic scalpel across 34 RCTs (Cirocchi et al., International Journal of Surgery 2024).
- Harmonic vs LigaSure in thyroidectomy: only 8.79 minutes faster, with no difference in blood loss or hospital stay (Upadhyaya et al., Biomedical Reports 2016).
- Laparoscopic colectomy: 42.09 mL more blood loss with monopolar scissors than with ultrasonic shears (Tou et al., Cochrane 2011).
- Cholecystectomy for acute cholecystitis: bile leak odds ratio 0.40 for ultrasonic vs electrocautery dissection across 28 RCTs (Moqbel et al., Surgical Endoscopy 2025).
- Mastectomy: sharp dissection had lower seroma odds than energy devices, OR 0.375, in a 33-RCT network meta-analysis (Oyewale et al., BMC Surgery 2024).
- 155 FDA 510(k) records under product code LFL (Instrument, Ultrasonic Surgical), 30 of them decided since January 2020 (openFDA 510(k) endpoint 2026).
- Overheating appeared in 6.9% of Harmonic MAUDE events vs 0.6% for LigaSure in head and neck surgery (Fritz et al., Head and Neck 2024).
1. How the Blade Works: Frequency, Travel and Heat
An ultrasonic scalpel does not pass electric current through the patient. A transducer in the handpiece turns electrical energy into mechanical vibration, and the blade moves back and forth tens of thousands of times per second; friction and pressure denature proteins in the tissue into a sticky coagulum that closes small vessels. That is why the headline numbers are a frequency and a travel distance (also called “excursion”: how far the blade tip moves on each stroke), not a wattage.
The surprise is the heat. Ultrasonic energy is often described as a low-temperature technique, yet the Harmonic ACE reached a mean peak of 195.9 ± 14.5 °C on swine peritoneum, roughly double the LigaSure V bipolar sealer (Kim et al., Surgical Endoscopy 2008). The hottest moment came after activation stopped, which is when a surgeon might rest the jaws against nearby tissue. The frequency and blade-travel figures come from the 2013 review of surgical energy by Sankaranarayanan et al. in Surgical Endoscopy. Most recent available data: Kim et al. 2008 and Sankaranarayanan et al. 2013.
| Metric | Value | Source |
|---|---|---|
| Harmonic Scalpel blade vibration frequency | 55.5 kHz | Sankaranarayanan et al., Surgical Endoscopy review 2013 |
| Longitudinal blade travel (excursion) at 55.5 kHz | 60 to 100 µm | Sankaranarayanan et al., Surgical Endoscopy review 2013 |
| Mean peak temperature on swine peritoneum: Harmonic ACE vs LigaSure V vs plasma trisector | 195.9 ± 14.5 °C vs 96.4 ± 4.1 °C vs 87 ± 2.2 °C | Kim et al., Surgical Endoscopy 2008 |
| Maximum Harmonic ACE temperature, reached just after the blade was switched off | 234.5 °C | Kim et al., Surgical Endoscopy 2008 |
| Cooling time of Harmonic ACE compared with LigaSure V and plasma trisector | About twice as long | Kim et al., Surgical Endoscopy 2008 |
Context note: the LigaSure V and plasma trisector stayed below 100 °C regardless of tissue type or whether they were on or off, while the Harmonic ACE went above 200 °C with a surge after deactivation (Kim et al., Surgical Endoscopy 2008). The idea of ultrasonic energy as a “low temperature” technique therefore describes the tissue effect, not the blade itself.
2. Vessel Sealing: Diameter Limits, Burst Pressure and Thermal Spread
Vessel sealing is judged on two numbers. Burst pressure is the internal pressure at which a sealed vessel starts to leak in a bench test, and lateral thermal spread is how far heat damage reaches sideways into tissue that was not meant to be treated. Early ultrasonic devices were small-vessel tools; the device generation cleared in 2013 claimed vessels up to 7 mm, the territory of bipolar sealers.
In a bench test on 5-7 mm porcine arteries, the median burst pressure was 1,419 mmHg with the Harmonic 7 in its advanced hemostasis mode vs 591 mmHg with LigaSure (Timm et al., Medical Devices 2014). Every author of that study was an Ethicon employee, and the clearance itself sits in the FDA 510(k) database entry K132612. The trade-off was time: the energy-modulated mode took more than twice as long as LigaSure to cut through a vessel. Most recent available data: Timm et al. 2014.
| Metric | Value | Source |
|---|---|---|
| Vessel diameter that early ultrasonic devices sealed best, and diameter above which they were judged unreliable | Up to 2 mm; unreliable above 3 mm (other cited studies: above 2 mm) | Sankaranarayanan et al., Surgical Endoscopy review 2013 |
| Indicated vessel size for HARMONIC ACE+7, 510(k) K132612 decided 17 October 2013 | Up to and including 7 mm | FDA 510(k) database 2013; Ethicon press release October 2013 (vendor’s own claim) |
| Median burst pressure, 3-5 mm porcine carotid arteries: Harmonic 7 advanced hemostasis mode vs LigaSure | 1,314 mmHg vs 836 mmHg (P=0.001) | Timm et al., Medical Devices 2014 (all authors employed by Ethicon) |
| Median burst pressure, 5-7 mm porcine carotid arteries: Harmonic 7 advanced hemostasis mode vs LigaSure | 1,419 mmHg vs 591 mmHg (P<0.001) | Timm et al., Medical Devices 2014 (all authors employed by Ethicon) |
| Mean time to cut through a vessel: Harmonic 7 advanced hemostasis mode vs LigaSure | 12.7 s vs 5.0 s | Timm et al., Medical Devices 2014 (all authors employed by Ethicon) |
| Lateral thermal damage on 6-7 mm goat vessels: Harmonic 7 vs LigaSure | 2.54 ± 0.48 mm vs 3.08 ± 0.67 mm (P=0.003) | Timm et al., Medical Devices 2014 (all authors employed by Ethicon) |
| Lateral thermal spread at high power with older ultrasonic devices (Ultracision, AutoSonix) | Up to 25.7 mm | Emam and Cuschieri, Annals of Surgery 2003, as summarised in Sankaranarayanan et al. 2013 |
Outlier note: the gap between 2.54 mm and 25.7 mm is not a contradiction so much as a warning about test conditions. Device generation, power level, activation time and tissue type all change the number, and the 2013 press release from Ethicon announcing the 510(k) clearance gave no independent sealing data.
3. Thyroidectomy: The Best-Studied Use
Thyroid surgery is where the randomized evidence is deepest, because the neck is crowded with small vessels, the parathyroid glands (which control blood calcium) and the recurrent laryngeal nerve, also called the inferior laryngeal nerve, which moves the vocal cord. Time saved is consistent across reviews from 2010 to 2024: from 23.1 to 27.62 minutes against clamp-and-tie in the two reviews below.
The 2024 review of 43 RCTs found transient low blood calcium in 11.3% of harmonic scalpel patients vs 15.4% after clamp-and-tie (Cirocchi et al., International Journal of Surgery 2024). Permanent nerve damage, the outcome with the longest-lasting effect on the voice, did not move: 0.57% vs 0.67%, a difference that was not statistically significant. For what follows when that nerve is injured, see our vocal fold paralysis treatment statistics and our roundup on laryngeal electromyography accuracy, the test used to assess nerve function. Against another advanced device rather than ties, the advantage shrinks to minutes (Upadhyaya et al., Biomedical Reports 2016).
| Metric | Value | Source |
|---|---|---|
| Mean operative time difference, FOCUS harmonic scalpel vs clamp-and-tie (34 of 43 RCTs, 6,481 patients) | -27.62 min (95% CI -31.84 to -23.40) | Cirocchi et al., International Journal of Surgery 2024 |
| Transient hypocalcaemia (low blood calcium), harmonic vs clamp-and-tie (36 RCTs) | 11.3% vs 15.4%, RR 0.67 (95% CI 0.56 to 0.81) | Cirocchi et al., International Journal of Surgery 2024 |
| Transient inferior laryngeal nerve palsy, harmonic vs clamp-and-tie (34 RCTs) | 3.99% vs 5.30%, RR 0.79 (95% CI 0.63 to 0.99) | Cirocchi et al., International Journal of Surgery 2024 |
| Permanent inferior laryngeal nerve palsy, harmonic vs clamp-and-tie (31 RCTs) | 0.57% vs 0.67%, RR 1.11 (95% CI 0.51 to 2.42) | Cirocchi et al., International Journal of Surgery 2024 |
| Operative time saved, earlier meta-analysis (9 RCTs, 822 patients) | 23.1 min (95% CI 13.8 to 32.33) | Melck and Wiseman, International Journal of Surgical Oncology 2010 |
| Hospital stay difference, Harmonic Focus vs conventional technique (9 studies; 14 RCTs, 2,516 patients in the review) | -0.68 days (95% CI -1.16 to -0.20) | Cheng et al., Thyroid Research 2015 (Ethicon-funded) |
| Intraoperative blood loss difference, Harmonic Focus vs conventional technique (6 studies) | -45.54 mL (95% CI -72.20 to -18.89) | Cheng et al., Thyroid Research 2015 (Ethicon-funded) |
| Operative time difference, harmonic scalpel vs LigaSure (7 RCTs, 981 patients) | -8.79 min (95% CI -15.91 to -1.67), P=0.02 | Upadhyaya et al., Biomedical Reports 2016 |
Context note: the 2010 meta-analysis by Melck and Wiseman re-ran its result without industry-funded trials and the saving held at 25 minutes (95% CI 16.3 to 33.62), which matters because the 2015 Thyroid Research review was funded by the manufacturer.
4. Abdominal Surgery: Colon, Stomach, Gallbladder and Liver
Outside the neck, the picture depends on what the ultrasonic device is compared against. Against monopolar electrosurgery or clamp-and-tie, ultrasonic dissection usually wins on blood loss. Against bipolar vessel sealers, the differences mostly vanish.
In laparoscopic colon surgery, 20.8% of patients randomized to standard electrosurgery were switched to the ultrasonic device during the operation (Morino et al., Annals of Surgery 2005), which suggests surgeons reach for it in the hardest steps rather than for every case. The Cochrane review of energy instruments for laparoscopic colectomy concluded that the evidence could not show which instrument is best. The two newest reviews, on gallbladder removal for acute cholecystitis and liver resection, both report fewer bile leaks with ultrasonic devices.
| Metric | Value | Source |
|---|---|---|
| Scope of the Cochrane review of energy instruments for laparoscopic colectomy | 6 RCTs, 446 participants | Tou et al., Cochrane Database of Systematic Reviews 2011 |
| Extra blood loss with monopolar scissors vs ultrasonic shears (2 RCTs, 186 participants) | MD 42.09 mL (95% CI 22.16 to 62.02) | Tou et al., Cochrane Database of Systematic Reviews 2011 |
| Blood loss, ultrasonic shears vs bipolar vessel sealer (2 RCTs, 181 participants) | MD -3.74 mL (95% CI -19.04 to 11.55), no clear difference | Tou et al., Cochrane Database of Systematic Reviews 2011 |
| Blood loss in laparoscopic colorectal resection, ultrasonic vs standard electrosurgery (146 patients randomized) | 140.8 mL vs 182.6 mL (P = 0.032) | Morino et al., Annals of Surgery 2005 |
| Patients randomized to electrosurgery who were switched to the ultrasonic device | 20.8% | Morino et al., Annals of Surgery 2005 |
| Blood loss in open gastrectomy, harmonic vs conventional technique (8 studies; 10 studies, 935 patients in the review) | MD -93.15 mL (95% CI -125.29 to -61.00) | Cheng et al., International Journal of Surgical Oncology 2015 (Ethicon-funded) |
| Bile leak, ultrasonic vs electrocautery in laparoscopic cholecystectomy for acute cholecystitis (20 of 28 RCTs, 3,383 patients in the review) | OR 0.40 (95% CI 0.27 to 0.61) | Moqbel et al., Surgical Endoscopy 2025 |
| Bile leak, ultrasonic devices vs clamp-crushing in liver resection (11 studies, 1,320 patients) | OR 0.57 (95% CI 0.35 to 0.93) | Yu et al., World Journal of Surgical Oncology 2024 |
Context note: the gastrectomy meta-analysis also found 27.50 minutes less operating time, but five of its eight authors were Ethicon employees and heterogeneity was high (I² = 91% for operating time). In the liver review, operating time did not differ significantly (WMD 2.28, 95% CI -6.95 to 11.50). Most recent available data for colectomy: Cochrane 2011.
5. Breast, Head and Neck, and Anorectal Surgery
These fields show the device at its least uniform. In mastectomy, the older pooled data favoured the harmonic scalpel on seroma (a fluid collection under the skin flap), but the newest network meta-analysis of randomized trials found plain scissors or a scalpel did better on seroma than energy devices as a group, while the harmonic scalpel still ranked well on flap necrosis (death of the skin flap).
In a 33-RCT network meta-analysis of 2,562 mastectomy patients, the harmonic scalpel lowered the odds of flap necrosis compared with diathermy, OR 0.379 (Oyewale et al., BMC Surgery 2024). Elsewhere, the head-to-head trials against other modern devices show little to choose: in hemorrhoid surgery against bipolar diathermy no outcome reached significance, and in tonsillectomy against coblation pain was slightly worse with the harmonic scalpel, a difference the authors judged not clinically meaningful.
| Metric | Value | Source |
|---|---|---|
| Seroma after modified radical mastectomy, harmonic scalpel vs electrocautery (10 studies) | OR 0.49 (95% CI 0.34 to 0.70) | Huang et al., PLoS One 2015 |
| Mean operative time in the same mastectomy comparison, harmonic vs electrocautery | 125 min vs 122 min, SMD 0.04 (P = 0.85) | Huang et al., PLoS One 2015 |
| Seroma, sharp dissection (scissors or scalpel) vs energy devices (33 RCTs) | OR 0.375 (95% credible interval 0.244 to 0.575) | Oyewale et al., BMC Surgery 2024 |
| Flap necrosis, harmonic scalpel vs diathermy | OR 0.379 (95% credible interval 0.177 to 0.791) | Oyewale et al., BMC Surgery 2024 |
| Operative time in neck dissection, harmonic vs conventional technique (10 RCTs, 558 patients) | -23.21 min (95% CI -34.30 to -12.12) | Hameed et al., Craniomaxillofacial Trauma and Reconstruction 2024 |
| Hemorrhoidectomy, harmonic scalpel vs bipolar diathermy (9 RCTs, 767 patients) | No significant difference on any outcome; operative time MD 3.14 min (P = 0.34) | Albazee et al., Cureus 2023 |
| Postoperative pain after tonsillectomy, harmonic scalpel vs coblation (5 RCTs, 10-point scale) | MD 0.40 (95% CI 0.10 to 0.69), favouring coblation | Albazee et al., Indian Journal of Otolaryngology and Head and Neck Surgery 2023 |
| Operative time in sleeve gastrectomy, LigaSure vs harmonic (367 patients) | MD -2.32 min (95% CI -10.86 to 6.21), P = 0.59 | Alharran et al., Cureus 2024 |
Context note: the 2015 PLoS One mastectomy analysis mixed randomized and non-randomized studies, while the 2024 BMC Surgery analysis was limited to RCTs, which is the main reason to weight the newer seroma result more heavily. The neck dissection review found less blood loss and drain output too, but did not state units for those outcomes. The sleeve gastrectomy review pooled only 4 studies, 2 of them randomized.
6. FDA Clearances and MAUDE Adverse Event Reports
Ultrasonic scalpels reach the US market through 510(k) premarket notification, which means FDA found them “substantially equivalent” to a device already on the market rather than approving them on new clinical trials. The paper trail is long: a Harmonic Scalpel reusable laparoscopic blade system was cleared in 1993, and the ultrasonic surgical instrument code still sees new entrants, including China-based makers such as Hunan Handlike (cleared 2024) and Shanghai Saints Sages Surgical (cleared 2025).
Searching MAUDE through the openFDA interface returns 54,179 reports with Harmonic in the brand name, of which 51,979 are malfunctions (openFDA device adverse event endpoint, data updated 13 October 2026). Yearly volume rose from 2,212 reports received in 2020 to 3,238 in 2025, a 46% increase ((3,238 - 2,212) / 2,212 = 46.4%), but FDA cautions that report counts reflect how often a device is used and how diligently events are reported, not how risky it is. The studies that classified these reports by hand point to the blade and to heat: Lee et al. for thyroid surgery, and Fritz et al. for head and neck surgery.
| Metric | Value | Source |
|---|---|---|
| 510(k) records under FDA product code LFL (Instrument, Ultrasonic Surgical), all years | 155 | openFDA 510(k) endpoint, queried October 2026 |
| LFL 510(k) decisions dated 1 January 2020 to 25 October 2026 | 30 | openFDA 510(k) endpoint, queried October 2026 |
| 510(k) for the Harmonic Scalpel Reusable Laparoscopic Blade System (Ultracision, Inc.) | K930352, decided 8 June 1993 | openFDA 510(k) endpoint, queried October 2026 |
| MAUDE reports with Harmonic in the brand name, all years: malfunction / injury / death as reported event type | 51,979 / 1,937 / 61 (54,179 in total) | openFDA device adverse event endpoint (MAUDE), data updated 13 October 2026 |
| Harmonic-brand MAUDE reports received in 2025 vs 2020 | 3,238 vs 2,212 | openFDA device adverse event endpoint (MAUDE), data updated 13 October 2026 |
| Share of thyroidectomy energy-device adverse events in MAUDE (2005-2020) that involved Harmonic | 394 of 620 (63.5%) | Lee et al., World Journal of Otorhinolaryngology-Head and Neck Surgery 2023 |
| Blade damage as a share of Harmonic device malfunctions in thyroidectomy reports | About 110 of 349 (31.5%) | Lee et al., World Journal of Otorhinolaryngology-Head and Neck Surgery 2023 |
| Overheating reports, Harmonic vs LigaSure in head and neck surgery (MAUDE, 2013-2023) | 6.9% vs 0.6% (p = 0.003) | Fritz et al., Head and Neck 2024 |
Context note: the 2025 split was 3,048 malfunctions, 188 injuries and 2 deaths as reported event type. A death report in MAUDE records that a death was mentioned in the report; it does not establish that the device caused it. Fritz et al. also found spontaneous self-activation in 4.4% of Harmonic reports vs 0% for LigaSure (p = 0.032), while intraoperative bleeding was reported more often with LigaSure (8.2% vs 0.0%, p = 0.001). The FDA MAUDE search page is updated monthly.
Summary: Ultrasonic Surgical Scalpel by the Numbers
| Metric | Value | Source |
|---|---|---|
| Harmonic ACE mean peak temperature on swine peritoneum vs LigaSure V | 195.9 °C vs 96.4 °C | Kim et al., Surgical Endoscopy 2008 |
| Indicated vessel size, HARMONIC ACE+7 (510(k) K132612, 2013) | Up to and including 7 mm | FDA 510(k) database 2013 |
| Median burst pressure, 5-7 mm arteries: Harmonic 7 vs LigaSure | 1,419 vs 591 mmHg | Timm et al., Medical Devices 2014 (Ethicon authors) |
| Thyroidectomy operative time, harmonic vs clamp-and-tie (34 RCTs) | -27.62 min | Cirocchi et al., International Journal of Surgery 2024 |
| Thyroidectomy operative time saved, 2010 meta-analysis of 9 RCTs | 23.1 min | Melck and Wiseman, International Journal of Surgical Oncology 2010 |
| Thyroidectomy operative time, harmonic vs LigaSure | -8.79 min | Upadhyaya et al., Biomedical Reports 2016 |
| Hospital stay, Harmonic Focus vs conventional thyroidectomy | -0.68 days | Cheng et al., Thyroid Research 2015 (Ethicon-funded) |
| Extra blood loss, monopolar scissors vs ultrasonic shears in laparoscopic colectomy | 42.09 mL | Tou et al., Cochrane Database of Systematic Reviews 2011 |
| Electrosurgery patients switched to the ultrasonic device in laparoscopic colorectal surgery | 20.8% | Morino et al., Annals of Surgery 2005 |
| Bile leak, ultrasonic vs electrocautery in cholecystectomy for acute cholecystitis | OR 0.40 | Moqbel et al., Surgical Endoscopy 2025 |
| Bile leak, ultrasonic devices vs clamp-crushing in liver resection | OR 0.57 | Yu et al., World Journal of Surgical Oncology 2024 |
| Flap necrosis after mastectomy, harmonic scalpel vs diathermy | OR 0.379 | Oyewale et al., BMC Surgery 2024 |
| Neck dissection operative time, harmonic vs conventional | -23.21 min | Hameed et al., Craniomaxillofacial Trauma and Reconstruction 2024 |
| 510(k) records under product code LFL, all years | 155 | openFDA 510(k) endpoint 2026 |
| MAUDE reports with Harmonic in the brand name, all years | 54,179 | openFDA device adverse event endpoint 2026 |
| Harmonic share of thyroidectomy energy-device MAUDE events (2005-2020) | 63.5% | Lee et al., World Journal of Otorhinolaryngology-Head and Neck Surgery 2023 |
Methodology and Sources
We ran targeted searches and then pulled each figure from the full text or abstract of the primary paper, or directly from FDA databases through the openFDA API. Where a review only summarised an older study, the Source cell names both. Manufacturer-funded or manufacturer-authored work is labelled as such in every table.
- Sankaranarayanan G et al., Common uses and cited complications of energy in surgery, Surgical Endoscopy 2013: PMC3755039
- Kim FJ et al., Temperature safety profile of laparoscopic devices: Harmonic ACE, Ligasure V and plasma trisector, Surgical Endoscopy 2008: PubMed 18027042
- Timm RW et al., Sealing vessels up to 7 mm in diameter solely with ultrasonic technology, Medical Devices: Evidence and Research 2014 (all authors Ethicon employees): PMC4124047
- US FDA, 510(k) Premarket Notification database, K132612 (HARMONIC ACE+ shears with Advanced Hemostasis): FDA 510(k) record
- Ethicon (Johnson and Johnson), press release on the HARMONIC ACE+7 510(k) clearance, October 2013 (vendor claim): jnj.com
- Cirocchi R et al., Sutureless FOCUS harmonic scalpel versus clamp-and-tie techniques for thyroidectomy: a meta-analysis of 43 randomized controlled trials, International Journal of Surgery 2024: PMC11634126
- Melck AL, Wiseman SM, Harmonic scalpel compared to conventional hemostasis in thyroid surgery: a meta-analysis of randomized clinical trials, International Journal of Surgical Oncology 2010: PMC3265258
- Cheng H et al., A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques, Thyroid Research 2015 (Ethicon-funded): PMC4589949
- Upadhyaya A et al., Harmonic versus LigaSure hemostasis technique in thyroid surgery: a meta-analysis, Biomedical Reports 2016: PMC4950612
- Tou S et al., Energy source instruments for laparoscopic colectomy, Cochrane Database of Systematic Reviews 2011: PMC12832166
- Morino M et al., Ultrasonic versus standard electric dissection in laparoscopic colorectal surgery: a prospective randomized clinical trial, Annals of Surgery 2005 (DOI 10.1097/01.sla.0000189607.38763.c5, read through its Europe PMC abstract record; also included in the Cochrane review above).
- Cheng H et al., Gastrectomy and D2 lymphadenectomy for gastric cancer: a meta-analysis comparing the harmonic scalpel to conventional techniques, International Journal of Surgical Oncology 2015 (Ethicon-funded): PMC4446499
- Moqbel I et al., Safety and efficacy of ultrasonic dissection versus electrocautery dissection in laparoscopic cholecystectomy for acute cholecystitis, Surgical Endoscopy 2025: PMC12500781
- Yu Z et al., Comparison of the outcomes between ultrasonic devices and clamping in hepatectomy: a meta-analysis, World Journal of Surgical Oncology 2024: PMC11568570
- Huang J et al., Harmonic scalpel versus electrocautery dissection in modified radical mastectomy for breast cancer: a meta-analysis, PLoS One 2015: PMC4636213
- Oyewale S et al., The effectiveness of different flap-raising techniques for mastectomy in reducing the rate of complications: a network meta-analysis, BMC Surgery 2024: PMC11665085
- Hameed I et al., Is using the harmonic scalpel better than conventional hemostasis in neck dissection? A meta-analysis, Craniomaxillofacial Trauma and Reconstruction 2024: PMC10874208
- Albazee E et al., Efficacy of harmonic scalpel versus bipolar diathermy in hemorrhoidectomy, Cureus 2023: PMC9904392
- Albazee E et al., Harmonic scalpel tonsillectomy versus coblation tonsillectomy, Indian Journal of Otolaryngology and Head and Neck Surgery 2023: PMC10646007
- Alharran AM et al., Efficacy of LigaSure versus Harmonic devices in laparoscopic sleeve gastrectomy, Cureus 2024: PMC10987252
- US FDA, openFDA device adverse event endpoint (MAUDE data, updated weekly; counts in this article retrieved October 2026, data last updated 13 October 2026) and openFDA 510(k) endpoint: open.fda.gov
- US FDA, MAUDE database search page: accessdata.fda.gov
- Lee E et al., Complications associated with energy-based devices during thyroidectomy from 2010-2020, World Journal of Otorhinolaryngology-Head and Neck Surgery 2023: PMC10050967
- Fritz CG et al., Comparing adverse events associated with LigaSure and Harmonic devices in head and neck surgery, Head and Neck 2024, volume 46, pages 378-385 (DOI 10.1002/hed.27593, read through its Crossref record and indexed abstract).
- Data watch: (1) The 55.5 kHz frequency in the 2013 review is sourced to a 2004 news article, and the 60 to 100 µm blade travel has no citation in that review; treat both as commonly quoted device values. (2) The burst pressure, 7 mm sealing and thermal damage figures in section 2 come from a study whose authors all worked for the manufacturer, and the 2015 Thyroid Research and gastrectomy meta-analyses were Ethicon-funded; the 2010 thyroid meta-analysis without industry-funded trials still found a 25-minute saving. (3) Cirocchi et al. 2024 gives -27.62 min for operative time in its Results but -59.52 min in its Discussion, and 5.30% vs 5.23% for clamp-and-tie transient nerve palsy; several of its printed percentages are truncated rather than rounded (for example 403 of 3,536 printed as 11.3%). We used the Results-section values. (4) Moqbel et al. 2025 has inconsistent arm sizes in its perforation data and a disclosure section that conflicts with its no-conflict statement; we reported only its pooled odds ratios. (5) Yu et al. 2024 gives 1,417 patients in its abstract and 4,493 in its Results; we used 1,417. (6) The openFDA counts search the word Harmonic in the brand-name field across all product codes, so they can include robotic and reprocessed Harmonic instruments; the LFL code also covers ultrasonic aspirators and bone devices, not only shears. MAUDE counts cannot be used to calculate complication rates. (7) Most recent available data for colectomy is the 2011 Cochrane review, and for device temperatures it is the 2008 Kim et al. study; an updated Cochrane review or independent bench data would change sections 1, 2 and 4.
Last updated: October 25, 2026. We update this roundup quarterly, and the next refresh is expected when the FDA publishes its next monthly MAUDE data release.