Johnson & Johnson‘s (NYSE:JNJ) Ethicon subsidiary late last month released a notice it filed in the Europe, the Middle East and Africa region warning of issues with its Intraluminal Staplers related to malformed staples and uncut washers that can “compromise staple line integrity.”
The company said that it initiated a medical device field safety corrective action for 378 lots of Intraluminal Staplers distributed in the region and that after investigating the complaints it found uncut washers and malformed staples in the devices.
“If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage or hemorrhagic shock,” the company wrote in its notice.
J&J’s Ethicon said that it has received reports of adverse events due to malformed staples, but that the occurrence of such events remains below 0.1%.
The company provided instructions for customers with the staplers, advising them to use a non-affected device if possible and requesting the return of identified products.
Ethicon said that in the case that an alternative device is not available, surgeons should adhere to a number of specific steps to avoid possible issues with the device.
In January, Ethicon released the results of a head-to-head study between an Ethicon surgical stapler and a Medtronic stapler system.