Surgical staplers and staples used for internal use have been linked to more than 41,000 medical device reports from Jan. 1, 2011 to March 31, 2018, and include 366 deaths, more than 9,000 serious injuries, and more than 32,000 device malfunctions, the U.S. Food and Drug Administration (FDA) informed health care providers.
Surgical staplers and staples are medical devices used in a wide range of surgical applications – including gastrointestinal, gynecologic, and thoracic surgeries – to remove part of an organ, to cut through organs and tissues, and to create connections between structures. The devices facilitate surgical procedures and may shorten the time it takes to perform surgical procedures compared to manual suturing.
The FDA said it believes that many of the problems with the staplers and staples identified in the reports can be attributed to the stapler functioning improperly or being used improperly. Some of the most commonly reported problems include:
- Opening of the staple line or malformation of staples;
- Difficulty in firing;
- Failure of the stapler to fire the staple; and
- Misapplied staples, (such as the user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
These issues may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.
“The agency’s analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk,” said William Maisel, M.D., M.P.H., chief medical officer in the FDA’s Center for Devices and Radiological Health.
The FDA is asking health care providers to implement new recommendations to improve the safe use of surgical staplers and staples. The agency will also convene an advisory committee meeting later this year “to discuss whether reclassifying surgical staplers for internal use as Class II medical devices would be appropriate.” The staplers are currently labeled as Class I, which is the lowest-risk category for medical devices and does not require premarket submission to the FDA. Implantable surgical staples are classified as Class II medical devices and require premarket review before marketing.
The FDA Letter to Health Care Providers and News Release came a day after Kaiser Health News published a scathing report about problems with surgical staplers noting the FDA kept the reports in a database that could not be accessed by doctors or the public.
FDA News Release