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

Derek A Benham; Richard Y Calvo; Matthew J Carr; Joseph A Diaz; C Beth Sise; Michael J Sise; Vishal Bansal; Matthew J Martin

doi:10.1016/j.amjsurg.2021.03.017

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

Am J Surg. 2021 Jun;221(6):1121-1126. doi: 10.1016/j.amjsurg.2021.03.017. Epub 2021 Mar 13.

Authors

Derek A Benham¹, Richard Y Calvo², Matthew J Carr³, Joseph A Diaz⁴, C Beth Sise⁵, Michael J Sise⁶, Vishal Bansal⁷, Matthew J Martin⁸

Affiliations

¹ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: benhamderek@gmail.com.
² Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: calvo.richard@scrippshealth.org.
³ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: carr.usn@gmail.com.
⁴ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: josephdiaz927@gmail.com.
⁵ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: sise.beth@scrippshealth.org.
⁶ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: sise.mike@scrippshealth.org.
⁷ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: bansal.vishal@scrippshealth.org.
⁸ Trauma Service, Scripps Mercy Hospital, 4077 Fifth Avenue, San Diego, CA, 92103, USA. Electronic address: martin.matthew@scrippshealth.org.

PMID: 33745689
DOI: 10.1016/j.amjsurg.2021.03.017

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.

MeSH terms

Databases, Factual
Equipment Failure / statistics & numerical data*
Equipment Failure Analysis
Humans
Retrospective Studies
Surgical Instruments / adverse effects*
United States
United States Food and Drug Administration