FDA finds 32,000 malfunctions, 366 deaths involving surgical staples over seven years

The Food and Drug Administration (FDA) is acknowledging a rise in medical device reports concerning surgical staples and staplers used internally. These staplers and staples are used in many aspects of medicine from gastrointestinal to thoracic surgeries. In a letter to health care providers, the FDA provided updated recommendations to reduce risk. It believes there are more pros than cons provided by staplers and staples and wants to update post-market actions.

“As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices,” said William Maisel, chief medical officer in the FDA's Center for Devices and Radiological Health.

As a result of ongoing assessments from Jan. 1, 2011 to March 31, 2018 for medical device reports, the FDA found more than 41,000 reports concerning surgical staplers and internal staples, including 366 deaths. There were over 32,000 malfunctions, including misfiring and misapplied staples. These problems can cause bleeding, increased surgical risk, tearing of internal tissues and organs, sepsis and death.

The FDA is reminding providers in this letter to review labeling instructions and to be more aware of their accuracy when choosing appropriate staple sizes. The letter also recommends providers take different actions when dealing with tissues that are swollen, may bleed or are necrotic and that staples may not be the best action when dealing with these circumstances.

Later this year, the FDA will have new draft guidance for stapler and staple manufacturers available for public comments. The FDA will also hold a public meeting with General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee to see if surgical staplers need to be reclassified from Class I to Class II. A reclassification would allow the FDA to mandate performance testing.