FDA issues warning about surgical staplers

The FDA just sent a letter to health care providers warning them about an increasing number of medical reports and complaints over the use of surgical staplers and implantable staples, which are often used in place of stitches to close up wounds. The agency said that it had analyzed over 41,000 reports about the devices from 2011 to early 2018 and found more than 360 deaths and over 9,000 serious injuries, with more than 32,000 malfunctions as a result of the tools. The most common complaints, the agency said, included a misfiring of the stapler and the opening up of stapled wounds. The agency also plans to issue this year a draft guidance on recommendations for device and staple manufacturers and information to include in product labeling.