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Ethicon Recalls Endo-Surgery Intraluminal Staplers

Ethicon has recalled its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples due to insufficient firing, which can compromise staple line integrity. According to a recall notice, surgeons use the devices in the “gastrointestinal tract for creating connections between structures (anastomoses) in surgical procedures.”


After investigating complaints and returned products, Ethicon confirmed uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to the insufficient firing, the notice says. “When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch,” it explains. “Failure to cut the washer suggests complete 360-degree staple line failure. In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in 3/2018 and continued through 3/2019, at which time the line was shut down.”

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