Ethicon recalled the devices due to an out-of-specification component within the jaw of the stapler in some devices, which could lead to malformed staplers. If a problem isn’t recognized or addressed, the malformed staples could lead to prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention or death, according to an FDA release.
The FDA said there were seven serious injuries and one death reported to Ethicon for the affected devices as of Oct. 3. Four different versions of the Echelon Flex Endopath stapler were recalled, with the product codes EC60A, PCEE60A, PLEE60A and PSEE60A included.
Ethicon’s Echelon Flex Endopath staplers are designed to cut and staple internal tissue in open or minimally invasive surgical procedures.
Earlier this month, Ethicon initiated a voluntary recall of its Echelon Flex Endopath 60mm staplers across seven different European countries due to potentially malformed staples. That recall came just after ECRI Institute said that surgical stapler misuse is the top health technology hazard in the 13th edition of its Top 10 Health Technology Hazards.
Earlier this year, the FDA published an analysis of nearly 110,000 stapler incidents reported since 2011. Among the incidents were 412 deaths, 11,181 serious injuries and 98,404 malfunctions. ECRI Institute said it has investigated 75 stapler incidents, including numerous fatalities, and published 42 safety alerts.
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