Adverse events related to suction electrocautery devices in adenotonsillectomy: Analysis of the MAUDE database

Abstract

Objective

To identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy.

Methods

The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms “suction cautery,” “suction electrocautery,” “suction Bovie,” and “suction coagulator” from January 2014 to December 2023.

Results

165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %).

Conclusion

The suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.