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

Abstract

Objective(s)Coblation, or radiofrequency ablation, and pulsed-electron avalanche knife (PEAK) plasmablade are newer approaches for tonsillectomy that reduce exposure to thermal heat. This study aims to describe and compare adverse events related to these devices for tonsillectomy. Study designRetrospective cross-sectional study. SettingThe US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database. MethodsThe MAUDE database was queried for reports involving coblation devices and the PEAK plasmablade from 2011 to 2021. Data were extracted from reports pertaining to tonsillectomy with and without adenoidectomy. ResultsThere were 331 reported adverse events for coblation and 207 for the plasmablade. For coblation, 53 (16.0 %) of these involved patients and 278 (84.0 %) were device malfunctions. Similarly for the plasmablade, 22 (10.6 %) involved patients and 185 (89.4 %) were device malfunctions. The most frequent patient-related adverse event was burn injury, which was significantly more common with the plasmablade compared to coblation (77.3 % vs. 50.9 %, respectively, p = 0.042). For both the coblator and plasmablade, the most common device malfunction was intraoperative tip or wire damage (16.9 % vs. 27.0 %, respectively, p = 0.010). The Plasmablade tip caught fire in five reports (2.7 %) with one causing burn injury. ConclusionsWhile coblation devices and the plasmablade have demonstrated utility in tonsillectomy with or without adenoidectomy, they are associated with adverse events. Plasmablade use may require greater caution for intraoperative fires and patient burn injuries compared to coblation use. Interventions to improve physician comfort with these devices may help reduce adverse events and inform preoperative discussions with patients.