Microdebrider complications in sinus surgery: Analysis of the openFDA database

Objective Functional endoscopic sinus surgery is a commonly performed otolaryngologic procedure that often uses the microdebrider device for tissue removal. Given ubiquitous nature of instrument, we sought to better define patterns failure using postmarket surveillance openFDA database. Methods The database was queried all microdebrider-related adverse events from January 1, 2000 November 2020. Descriptive information on and any associated patient injury compiled. Reports not directly related were excluded analysis. Results A total 641 included in most common overheating (n = 348, 54.3%), followed by material separation 173, 27%), inconsistent activation 52, 8.1%). Of reported events, vast majority did result harm 579, 90.3%). On review remaining cases, only 24 (3.7%) resulted true patient, defined as temporary or permanent >30 min additional anesthesia time. these need reschedule surgical cases 5, 0.8%), retained foreign body thermal 3,0.5%) common. Five patients suffered an due surgeon error unrelated malfunction 0.8%). Conclusions Microdebrider failures are extremely rare. When they do occur, less than 10% harm. In failure, preoperative testing before use could prevent many malfunctions.