FDA Thursday labeled a recall of more than 92,000 circular staplers made by Ethicon as Class I, or high risk. The Johnson & Johnson company's device may cause harm or death, FDA warned after learning certain patients suffered serious injuries due to stapler malfunction. The recall was initiated April 11.
Misfiring staplers resulted in additional resections of the rectum in two patients, FDA said, solidifying concerns faulty devices may cause lifelong problems and deaths. The recalled devices were manufactured and distributed between March 2018 and March 2019.
FDA has proposed shifting regulation of all surgical staplers from Class I to Class II in light of these risks, building on evidence implicating the category of devices in 366 deaths over a seven-year period. The agency's General and Plastic Surgery Devices Panel will weigh in on the potential changes in a meeting May 30-31.
Surgical staplers are designed so physicians can work faster than is possible using manual suturing, resulting in proliferation of the devices for use in a wide range of procedures. However, FDA issued an alert in March revealing it had received more than 41,000 medical device reports for surgical staplers and staples for internal use from 2011 to 2018, including many cases of misfired and malformed staples.
The following month, Ethicon began recalling 92,496 devices from the U.S. In a field safety corrective action flagged by regulators in the U.K., Ethicon said its investigations of complaints and returned products had "confirmed occurrence of uncut washers and malformed staples" that can "compromise staple line integrity."
When the devices function properly, they should cut the washer, delivering a crunch that the surgeon hears and feels to confirm the firing cycle is complete. The presence of uncut washers in the Ethicon staplers suggests "complete 360-degree staple line failure," FDA wrote in its recall notice.
Ethicon's investigation revealed a shift in the manufacturing process in March 2018 and continued until it shut down the production line a year later. The recall affects Endo-Surgery Curved Intraluminal Staplers and Endo-Surgery Endoscopic Curved Intraluminal Staplers made over that 12-month period.
FDA classed the recall as a Class I event, meaning the devices pose a risk of serious patient harm or death. The classification reflects the fact Ethicon's misfiring staplers led patients to have middle and lower rectum resections during procedures intended to resect the upper rectum. Death, sepsis and permanent ostomy bag use are among the potential consequences.
FDA is advising surgeons to returned affected products for replacement by June 30, and consider using different staplers or alternative approaches, such as hand-sewn closures and minimally-invasive procedures.
Stricter regulation of surgical staplers may be on the horizon. FDA recently outlined plans to move staplers into Class II, meaning they would need to undergo a review before coming to market. FDA is also considering implementing stronger controls and adopt new rules on product labeling.