J & amp;J Recalls Ethicon Circular Staplers

Through investigation of complaints and returned products, Johnson & Johnson's Ethicon business confirmed uncut washers in the stapler and malformed staples occur with its intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. 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, FDA noted. Surgeons use Ethicon Endo-Surgery Intraluminal Staplers in the gastrointestinal tract for creating connections between structures (anastomoses) in surgical procedures. The company confirmed serious device-related injuries to two patients. Misfiring of the stapler resulted in an additional resection (of the middle rectum in one patient and the lower rectum in another patient) during the planned resection of the upper rectum. A recent investigation detected a shift in the manufacturing process and the line was shut down in early March. The shift in the process had occurred for about a year before the problem was discovered. FDA said using the affected product may cause serious patient harm or death, and the agency identified the recall as a Class I recall, its most serious recall class. Potential risks to patients include death, sepsis, bleeding, the need for a permanent ostomy bag, life-long nutritional and digestive issues, leak in the closure (anast...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news