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

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.

Medico-legal liability of injuries arising from laryngoscopy.

OBJECTIVE: Dental and mucosal injuries from laryngoscopy in the peri-operative period are common medico-legal complaints. This study investigated lawsuits arising from laryngoscopy. METHODS: Westlaw, a legal database containing trial records from across the USA, was retrospectively reviewed. Plaintiff and/or defendant characteristics, claimed injuries, legal outcomes and awards were extracted. RESULTS: Of all laryngoscopy-related dental or mucosal injuries brought before a state or federal court, none (0 per cent) resulted in a defence verdict against the provider or monetary gain for the patient. Rulings in the patient's favour were observed only when laryngoscopy was found to be the proximate cause of multiple compounding complications that culminated in severe medical outcomes such as exsanguination, septic shock or cardiopulmonary arrest. CONCLUSION: Proper laryngoscopy technique and a robust informed-consent process that accurately sets patients' expectations reduces litigation risk. Future litigation pursuits should consider the low likelihood of malpractice allegation success at trial.