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Complications Associated with Microdebriders in Otolaryngology Procedures from 2011 to 2021: A MAUDE Study
Hari Magge1, Esther Lee1, Timothy B Shaver1
1Division of Otolaryngology-Head and Neck Surgery George Washington University School of Medicine & Health Sciences Washington District of Columbia USA.
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.
Insights
Microdebrider use in otolaryngology presents risks, with broken parts and overheating causing malfunctions. Understanding these device risks, like unintentional tissue damage, aids physicians in patient care and complication management.
Area of Science:
- Otolaryngology
- Medical Device Safety
- Surgical Technology
Background:
- Microdebriders are essential powered surgical instruments in otolaryngology.
- Device malfunctions and patient complications necessitate thorough risk assessment.
Purpose of the Study:
- To identify the types and frequency of microdebrider malfunctions.
- To document patient complications and subsequent interventions.
- To analyze adverse events reported to the FDA MAUDE database.
Main Methods:
- Cross-sectional analysis of the FDA MAUDE database from 2011 to 2021.
- Queried for "microdebrider" adverse events in head and neck surgeries.
- Filtered reports for specific usage and injury details.
Main Results:
- 282 adverse events reported in 267 Medical Device Reports (MDRs).
- Most common malfunction: broken parts (48.2%) and motor overheating (31.3%).
- Most frequent patient injury: unintentional tissue damage (32.3%).
Conclusions:
- Microdebrider utility in otolaryngology is significant but carries risks.
- Device malfunctions can lead to patient injuries such as tissue damage, burns, and bleeds.
- Awareness of these risks improves physician preparedness and patient education.
