Ethicon, a subsidary of Johnson & Johnson which manufactures surgical sutures and wound closure devices, has recalled 92,496 intraluminal circular surgical staplers due to insufficient firing and failure to completely form staples. Identified by the FDA as a Class 1 recall –the most serious type of recall — the recalled products include the Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and the Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples used by surgeons for creating connections between structures in surgical procedures.
The use of the defective intraluminal circular staplers may cause serious patient harm or death, and affects patients who have had or may undergo gastrointestional surgery, such as patients with colorectal cancer and bariatric patients. Potential risks to patients include death, sepsis, bleeding, the need for permanent ostomy “bag,” life-long nutritional and digestive issues, leak in the closure, additional surgeries, need for additional closures, need for antibiotics, and the need for additional imaging studies.
As confirmed by Ethicon, two patients suffered serious injuries when the stapler misfired, resulting 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.
Through investigation of complaints and returned products, Ethicon also 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. 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. An investigation into the manufacturing process also detected a shift in a process, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.
If you or someone you love has suffered serious injuries or death due to a surgical stapler malfunction, file a report with MedWatch: The FDA Safety Information and Adverse Event Reporting Program and consult with an experienced product liability attorney at Panish | Shea | Boyle | Ravipudi LLP to discuss your potential claim.