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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.
Objective:
Functional endoscopic sinus surgery is a commonly performed otolaryngologic procedure that often uses the microdebrider device for tissue removal. Given the ubiquitous nature of the instrument, we sought to better define the patterns of device failure using the postmarket surveillance openFDA database.
Methods:
The openFDA database was queried for all microdebrider-related adverse events from January 1, 2000 to November 1, 2020. Descriptive information on the nature of device failure and any associated patient injury was compiled. Reports not directly related to device failure were excluded from the analysis.
Results:
A total of 641 events were included in the analysis. The most common device failure was overheating (n = 348, 54.3%), followed by material separation (n = 173, 27%), and inconsistent device activation (n = 52, 8.1%). Of the reported events, the vast majority did not result in patient harm (n = 579, 90.3%). On review of the remaining cases, only 24 events (3.7%) resulted in true harm to the patient, defined as a temporary or permanent injury or >30 min of additional anesthesia time. Of these cases, the need to reschedule surgical cases (n = 5, 0.8%), retained foreign body (n = 5, 0.8%), and thermal tissue injury (n = 3,0.5%) were the most common. Five patients suffered an injury due to surgeon error unrelated to device malfunction (n = 5, 0.8%).
Conclusions:
Microdebrider device failures are extremely rare. When they do occur, less than 10% result in patient harm. In cases of patient harm related to microdebrider failure, preoperative testing of the device before use could prevent many of the reported malfunctions.
Insights
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.
