As federal regulators continues a campaign to improve the safety of surgical staplers, Ethicon has recalled nearly 100,000 devices, due to problems with the firing sequence, which could result in serious patient injuries or deaths.
The FDA announced an Ethicon Endo-Surgery Stapler recall on May 16, warning that the device has been linked to reports of insufficient firing, which can result in circular staples failing.
Ethicon has received at least two reports of serious injuries to patients, and the FDA has classified this as a Class I recall, the most serious classification, and an indication that problems with the staplers can result in patient injury or death.
The affected staplers are used for creating connections between structures in the gastrointestinal tract during surgical procedures. In both of the reported injuries, patients had to undergo a surgical resection of parts of their rectum due to staple failures.
“Through investigation of complaints and returned products, Ethicon 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,” the recall notice warns. “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.”
Manufacturing of the affected staples was halted in March after problems were discovered in the production process, the FDA reports.
The recall impacts the Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples, and the Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples. They were sold under product codes CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, and ECS33A. The product codes are located on the front of the single unit cartons.
The recall includes 92,496 devices in the United States. Which were manufactured between March 6, 2018 and March 6, 2019, and were distributed from March 15, 2018 to March 8, 2019.
FDA Surgical Stapler Concerns
Last month, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and to classify them as moderate risk medical devices. They are currently classified as low-risk devices.
The new classification would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions.
The most commonly reported surgical stapler problems involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warning indicates that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.
In 2012, Ethicon had to recall more than 150,000 of its Endo-Surgical circular staplers due to similar problems. The Ethicon surgical stapler recall came after surgeons began abandoning use of the devices during surgical procedures because they had so many problems firing them.
Three years later, in 2015, a California jury awarded nearly $80 million to a retired San Jose police officer whose anal canal was accidentally sealed by a defective Ethicon surgical stapler.
The FDA indicates Ethicon notified affected customers of this most recent recall last month, and provided instructions to health care facilities, distributors and other customers on what to do with the staplers. The instructions called for them to quarantine any affected products, remove it from use or distribution, and to communicate with relevant operating room or materials management personnel, or anyone who may use the staplers.
Ethicon also provided instructions on how to return those affected by the recall and to receive replacement products. Those affected staplers must be returned by June 30, 2019 in order to receive a replacement.
Customers returning recalled staplers can contact Stericycle at 1-888-671-8832 and reference Event #5011. Those with additional questions can contact Ethicon Customer Support Center at 1-877-384-4266.
Anyone who has experienced a problem with the staplers is encouraged to report the incident to the FDA’s MedWatch adverse event reporting program.