Comparing adverse events associated with LigaSure and Harmonic devices in head and neck surgery

• Published in: Head & neck Vol. 46; no. 2; pp. 378 - 385
• Main Authors: Fritz, Christian G., Monos, Stylianos D., Panara, Kush, Rajasekaran, Karthik
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.02.2024; Wiley Subscription Services, Inc
• Subjects: Adverse events; complications; Databases, Factual; Harmonic; Head and neck; Humans; LigaSure; MAUDE; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Retrospective Studies; Surgical Instruments; Harmonic; MAUDE; adverse events; complications; LigaSure
• ISSN: 1043-3074; 1097-0347; 1097-0347
• DOI: 10.1002/hed.27593

Objective To characterize adverse events, provide a safety profile, and understand patient outcomes after complications arising from LigaSure and Harmonic use in the head and neck region. Methods Retrospective analysis of adverse events from the Manufacturer and User Facility Device Experience (MAUDE) between January 2013 and 2023. Results A total of 158 LigaSure and 159 Harmonic events were extracted. There were significantly more reports of Harmonic device overheating (6.9% vs. 0.6%, p = 0.003) and spontaneous self‐activation (4.4% vs. 0%, p = 0.032). Although intra‐operative and post‐operative complications were similar among both groups, there were significantly more intra‐operative bleeding events for LigaSure as compared to Harmonic (8.2% vs. 0.0%, p = 0.001). Conclusion Understanding technical complications and adverse events attributable to LigaSure and Harmonic devices enables the development of clinically relevant risk mitigation strategies. Surgeons should avoid improper use by remaining vigilant of device functionality and temperature changes.