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U.S. Department of Health and Human Services

Medical Devices

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Other Data

Between November 14, 1994 and July 1, 2001 FDA received 112 surgical stapler adverse event death reports. The death reports involved staplers that did not fire or staples that did not form properly. There are also reports of suture line separation from staples that did not form or fell off. Physicians and other health care professionals should be aware of problems with surgical staplers and report deaths, serious injuries, or malfunctions to the manufacturer or distributor. A study is underway to characterize deaths, injuries, and malfunctions.

The following staplers were involved in the reported Adverse Events:

  • Endoscopic linear cutters
  • Articulating linear staplers
  • Curved intraluminal staplers
  • Multiple clip appliers
  • Disposable autosuture

The majority of the events occurred during gastrointestinal surgeries (65%) or plumonary procedures (19%). Other surgery sites involved the cardiac, circulatory, hepatic and nephrotic systems, and sites unspecified. However, these reports do not establish a causal link between the reported device and adverse events. The reports provide a signal to manufacturers, regulators, and device users to help identify potential problems with surgical staplers.

The following graphs and tables illustrate the data collected from the 112 adverse event (MDR) reports.

Devices and Product Codesn

Surgical Staplers (GAG)80
Surgical Clip Appliers (GDO)10
Endoscope Accessories (KOG)10
Laparoscope, general & plastic (GCJ)9
Implantable Clip (FZP)2
Implantable Staple (GDW)1
Patient Problems N(%). Infection, sepsis: 17 (15.2). Surgery (additional, repeat, or prolonged) 35 (31.2). Anastomoses failure, 45 (40.2). Bleeding, exsanguination, hemorrhage, 33 (29.5).
Device Problems N(%). Suture line separation, 16 (14.3). Staples did not form, 36 (32.1). Failures*, 33 (29.5). * Failures include codes for device failure, didn't fire properly, failed to fire, misfired, malfunction, application problem.Patient Gender N(%). Unknown, 55 (49.1). Female, 23 (20.5). Male, 34 (30.5). Patient age, 65 plus or minus 15. (Range 22-91.)