FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.
The agency’s ongoing analysis of stapler- and internal-staple-related adverse event reports from Jan. 1, 2011 to March 31, 2018, also revealed more than 9,000 serious injuries and over 32,000 malfunctions. FDA attributed many of the problems to the staplers themselves because proper staple formation depends largely on proper function and use of the stapler.
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