Johnson & Johnson’s Ethicon, Inc. subsidiary has recalled thousands of internal surgical staplers, following reports that they misfired or failed to completely form staples during procedures.
The U.S. Food & Drug Administration (FDA) has granted the surgical stapler recall Class I status, a clear indication that these devices pose a significant risk of patient harm or death.
According the recall notes posted at the agency’s website on May 16th, this action involves:
Ethicon manufactured these surgical stapler systems from March 6, 2018 through March 6, 2019, and distributed more than 92,400 devices to customers across the United States from March 15, 2018 through May 8, 2019.
The recalled staplers bear the following product codes on the front of their cartons: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, and ECS33A.
Healthcare facilities, distributors, and other customers should inspect their inventories and quarantine any affected devices as soon as possible. Ethicon will only provide replacement staplers to customers that return the recalled products by June 30, 2019.
The Ethicon surgical stapler recall follows at least two confirmed patient injuries. Both individuals were undergoing a resection of the upper rectum when a stapler misfired, resulting in the need for an additional resection — of the middle rectum in one patient and the lower rectum in another — during the procedure.
Other consequences of surgical stapler misfire include:
“Through investigation of complaints and returned products, Ethicon confirmed uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity,” the agency noted. “When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure.”
Ethicon’s internal investigation also uncovered a shift in the manufacturing process, which occurred in March 2018 and continued through March 8, 2019, when the line shut down.
Surgeons utilize internal staplers to create connections, remove organs, and cut through tissue during a range of procedures, including gastrointestinal, thoracic, and gynecological surgeries.
The FDA currently regulates internal surgical staplers as Class I (low risk) medical devices, and doesn’t require manufacturers to seek regulatory approval before bringing their products to market. However, after they were implicated in thousands of reported injuries and malfunctions, the agency proposed reclassifying internal staplers as moderate (Class II) medical devices.
Next Thursday, the FDA will convene a meeting of its General & Plastic Surgery Devices Panel to discuss whether or not such action is warranted.