Complications Associated with Microdebriders in Otolaryngology Procedures from 2011 to 2021: A MAUDE Study

Document Type

Journal Article

Publication Date

1-1-2023

Journal

OTO open

Volume

7

Issue

4

DOI

10.1002/oto2.83

Keywords

MAUDE; adverse events; endoscopic sinus surgery; microdebrider; patient safety

Abstract

OBJECTIVE: The microdebrider is a powered surgical instrument that is widely used in the field of otolaryngology. We aim to identify the type and frequency of device malfunctions, patient complications, and subsequent interventions related to the use of microdebriders. STUDY DESIGN: Cross-sectional analysis. SETTING: The US Food and Drug Administration (FDA) 2011 to 2021 Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried for reports of "microdebrider," with adverse events selected that pertained to usage in head and neck surgeries from January 1, 2011 to December 31, 2021. RESULTS: There were 282 adverse events in 267 individual medical device reports (MDR). Although the majority of the reports did not specify the specific operation, endoscopic sinus surgery was the most common reported procedure (89, 33.3%). The most common cause of device malfunction was due to a broken piece (120, 48.2%) followed by overheating of the microdebrider motor (78, 31.3%). Of the reports which specified patient injury, the most commonly reported was "unintentional tissue damage," (10, 32.3%). CONCLUSION: The microdebrider has demonstrated utility within the field of otolaryngology, but is not without risk of malfunction that can cause patient injury. By understanding possible risks of microdebrider usage, including tissue damage, burns, and bleeds caused by device malfunction or operator error, physicians can be better prepared to address complications and educate patients.

Department

Surgery

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