Comparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy.

Area of Science:

• Otolaryngology
• Minimally Invasive Surgery
• Medical Device Safety

Background:

• Coblation and PEAK plasmablade are newer tonsillectomy techniques reducing thermal heat exposure.
• Understanding adverse events associated with these devices is crucial for patient safety.

Purpose of the Study:

• To describe and compare adverse events associated with coblation and PEAK plasmablade devices during tonsillectomy.
• To identify specific risks and device malfunctions for each technology.

Main Methods:

• Retrospective cross-sectional study utilizing the FDA MAUDE database.
• Analysis of adverse event reports for coblation and PEAK plasmablade from 2011 to 2021.
• Inclusion of tonsillectomy reports, with or without adenoidectomy.

Main Results:

• 331 adverse events reported for coblation and 207 for PEAK plasmablade.
• Patient-related events were more common with PEAK plasmablade (10.6%) vs. coblation (16.0%), with burns being more frequent with PEAK plasmablade (77.3% vs. 50.9%).
• Intraoperative tip or wire damage was the most common device malfunction for both, more frequent with PEAK plasmablade (27.0% vs. 16.9%). PEAK plasmablade had 5 reports of fire.

Conclusions:

• Both coblation and PEAK plasmablade are associated with adverse events during tonsillectomy.
• PEAK plasmablade use necessitates greater caution regarding intraoperative fires and patient burns compared to coblation.
• Improving physician familiarity and informing patient discussions are key to mitigating risks.