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

Erin M Gawel1, Katelin R Keenehan1, Deepthi S Akella2

  • 1Jacobs School Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, United States of America.

American Journal of Otolaryngology
|July 27, 2024
PubMed
Abstract

Insights

Suction electrocautery devices can malfunction during adenotonsillectomy, leading to patient thermal burns. Inadequate insulation is a primary cause of these adverse events.

Area of Science:

  • Otolaryngology
  • Medical Device Safety
  • Surgical Complications

Background:

  • Suction electrocautery is utilized in adenotonsillectomy.
  • Potential adverse events (AEs) associated with this device require investigation.

Purpose of the Study:

  • To identify and analyze AEs linked to suction electrocautery during adenotonsillectomy.
  • To determine the types and causes of device-related injuries.

Main Methods:

  • A retrospective analysis of the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
  • Search terms included "suction cautery," "suction electrocautery," "suction Bovie," and "suction coagulator" from January 2014 to December 2023.

Main Results:

  • 165 AE reports were identified; 36 met inclusion criteria.
  • Patient injuries, primarily thermal burns (61.1%), occurred in 22 reports.
  • Common burn sites included the lip, oral commissure, and tongue; inadequate insulation was the leading cause of AEs (19.4%).

Conclusions:

  • Suction electrocautery devices pose a risk of malfunction and patient thermal burns.
  • Inadequate insulation, coagulation issues, and component detachment are key failure points.
  • Surgeons should be aware of these risks and counsel patients/parents on potential AEs.
Keywords:
AdenotonsillectomyAdverse eventsDevice failureElectrocauteryMAUDE

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