The FDA is warning healthcare providers about the risk of serious injury, malfunction and death associated with surgical staplers and implantable surgical staples.
Between January 2011 and March 2018, the FDA has received more than 41,000 individual adverse event reports, including 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions related to surgical staples and staplers.
The most commonly reported problems were opening of the staple line, misfiring of the stapler and applying the wrong staples to the tissue, the agency said.
The FDA sent a letter to healthcare providers reminding them of the risks and offered recommendations to help improve the safety of the devices.
The agency said that when the staplers and staples are used correctly, they can enable surgeons to perform less-invasive operations.