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Microdebrider complications in sinus surgery: Analysis of the openFDA database
Elias S Saba1, Jacob Hoerter1, Jeremy Chang2
1Department of Head and Neck Surgery Kaiser Permanente Oakland Medical Center Oakland California USA.
World Journal of Otorhinolaryngology - Head and Neck Surgery
|December 7, 2023
Summary
Microdebrider device failures during sinus surgery are rare, with overheating being the most common issue. Most failures do not cause patient harm, and preoperative testing can prevent malfunctions.
Area of Science:
- Otolaryngology
- Medical Device Safety
- Surgical Technology
Background:
- Functional endoscopic sinus surgery frequently utilizes microdebrider devices for tissue removal.
- Understanding microdebrider device failure patterns is crucial due to its widespread use.
Purpose of the Study:
- To analyze microdebrider device failure patterns using the postmarket surveillance openFDA database.
- To identify the types of failures and associated patient injuries.
Main Methods:
- The openFDA database was queried for microdebrider-related adverse events from 2000 to 2020.
- Data on device failure nature and patient injury were compiled, excluding unrelated events.
Main Results:
- 641 events were analyzed; the most common failures were overheating (54.3%), material separation (27%), and inconsistent activation (8.1%).
- Over 90% of events did not result in patient harm; only 3.7% caused injury.
- The most frequent harms included surgical case rescheduling, retained foreign bodies, and thermal tissue injury.
Conclusions:
- Microdebrider device failures are infrequent, with a low incidence of patient harm (<10%).
- Preoperative device testing is recommended to mitigate malfunctions and prevent patient injury.
