The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use and is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with these devices. In addition, we are announcing new actions we intend to take to help ensure the safe use of these devices.
Because surgical staplers and staples for internal use are used as a system, the FDA analyzed the medical device reports submitted for both surgical staplers and implantable staples to obtain a comprehensive picture of the safety profile for these devices. Our analysis, which is ongoing, found that from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:
- 366 deaths,
- over 9,000 serious injuries, and
- over 32,000 malfunctions.
The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.