Class I recall: Ethicon circular staplers fire insufficiently and fail to completely form staples

The Food and Drug Administration released a Class I recall alert for Ethicon’s Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples.

FDA said after the company investigated complaints and received returned products, it confirmed that 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. In addition, Ethicon’s manufacturing process was investigated and a shift in a process was identified, which occurred in March 2018 and continued through March 8, 2019, at which time the line was shut down.

Those who may be affected include surgeons who have performed gastrointestinal surgeries and patients who have had or may undergo gastrointestinal surgery, such as patients with colorectal cancer and bariatric patients. The FDA has identified this as a Class I recall, the most serious type of recall, noting use of these devices may cause serious injuries or death, which according to the agency, has already occurred during bowel surgery on two patients,

Ethicon confirmed serious injuries to two patients, said FDA.  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. 

Potential risks to patients include death, sepsis, bleeding, the need for permanent ostomy "bag," life-long nutritional and digestive issues, leak in the closure (anastomotic leak), additional surgeries, need for additional closures (anastomoses), need for antibiotics, and the need for additional imaging studies.

The FDA's recent letter to healthcare providers on surgical staplers and staples includes general recommendations for surgeons, noting that surgeons who typically use these staplers have other options, including using manual staplers from other manufacturers, and powered staplers from Ethicon or other manufacturers.

Additionally, FDA suggested that surgeons who typically use these staplers may consider performing an alternative approach to the surgery, such as open surgery with an alternative of handsewn closure (anastomosis), delayed surgery, and minimally invasive surgery.

On April 11, 2019, Ethicon notified customers who purchased the affected staplers (visit FDA for product codes)and told healthcare facilities, distributors, and other customers to examine inventory immediately to determine if the recalled product is on hand and quarantine such product(s). It also told healthcare facilities to communicate the issue to relevant operating room and materials management personnel and others who need to be informed.