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J Am Coll Surg. 2004 Sep;199(3):374-81.

Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration.

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1
Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.

Abstract

BACKGROUND:

Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure. The Food and Drug Administration (FDA) regulates surgical staplers as a medical device. Manufacturers and health-care providers report adverse events occurring during the use of surgical staplers to the FDA.

STUDY DESIGN:

Two FDA adverse event databases, the Manufacturer and User Facility Device Experience database and the Alternative Summary Reporting database were searched for adverse events related to the use of surgical staplers. An FDA recall database, Oracle System Center Automated Retrieval, was searched for surgical stapler recalls and the reason for these recalls.

RESULTS:

We characterized adverse events from 112 death, 2,180 injury, and 22,804 malfunction reports from FDA adverse event databases. We described 22 recalls for these products that are listed in an FDA database. A majority of these recalls were related to manufacturing or design problems.

CONCLUSIONS:

The overall incidence of these events remains unknown; because these products are used so frequently, even uncommon adverse events may affect many patients. It is important for health-care providers to report adverse events to manufacturers so that they may work to improve the design of these devices and reduce use errors that contribute to the events.

[Indexed for MEDLINE]

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