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Revealing the scope of surgical device malfunctions: Analysis of the "hidden" Food and Drug Administration device

Derek A Benham¹, Richard Y Calvo¹, Matthew J Carr¹

¹Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA.

American Journal of Surgery

|March 22, 2021

Abstract

Background:

We compared surgical device malfunction reports in the Food and Drug Administration (FDA) public Manufacturer and User Facility Device Experience (MAUDE) with those in the FDA nonpublic Alternative Summary Reporting (ASR).

Methods:

General surgery device product code categories in MAUDE and ASR from 1999 to 2018 were identified. Changes in the rates of categories and adverse events were evaluated by Poisson regression.

Results:

There were 283,308 (72%) general surgical device malfunctions in MAUDE and 109,954 (28%) in ASR. Reports increased annually in ASR versus MAUDE, particularly for surgical staplers and clip devices (p < 0.05). ASR contained approximately 80% of these reports; MAUDE 20%. In MAUDE, 42.9% of surgical device malfunctions and 20.2% of stapler/clip malfunctions resulted in patient injury or death. ASR listed no injury or death information.

Conclusions:

ASR contained a significant portion of surgical device malfunctions hidden from public scrutiny. Access to such data is essential to safe surgical care.

Keywords:

Malfunction Misfire Surgical device Surgical stapler

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