![]() ![]() Surgeons can operate with confidence across a broader range of tissue thickness and lower in the pelvis compared to Ethicon Contour ®* (,)įor thoracic procedures, the unique design and 360 degree rotation provides multiple angles and enhances access in the chest cavity for both open and VATS procedures compared to linear reloads. It may provide surgeons uncompromised access and visibility deep in the pelvis. In colorectal procedures, the Endo GIA™ radial reload is setting new standards for access, maneuverability and staple line security in LAR procedures. Those with additional questions can contact Ethicon Customer Support Center at 1-87.Īnyone who has experienced a problem with the staplers is encouraged to report the incident to the FDA’s MedWatch adverse event reporting program.With the thickest indicated tissue range for any stapler on the market (2.25 mm – 3.00 mm) 1, the Endo GIA™ radial reload delivers optimal performance, even in challenging cases. Those affected staplers must be returned by Jin order to receive a replacement.Ĭustomers returning recalled staplers can contact Stericycle at 1-88 and reference Event #5011. ![]() 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.Įthicon also provided instructions on how to return those affected by the recall and to receive replacement products. 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. 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 Ethicon surgical stapler recall came after surgeons began abandoning use of the devices during surgical procedures because they had so many problems firing them. In 2012, Ethicon had to recall more than 150,000 of its Endo-Surgical circular staplers due to similar problems. 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. 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 new classification would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions. They are currently classified as low-risk devices. Last month, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and to classify them as moderate risk medical devices. Which were manufactured between Maand March 6, 2019, and were distributed from Mato March 8, 2019. The recall includes 92,496 devices in the United States. The product codes are located on the front of the single unit cartons. ![]() They were sold under product codes CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, and ECS33A. ![]() 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. Manufacturing of the affected staples was halted in March after problems were discovered in the production process, the FDA reports. Failure to cut the washer suggests complete 360-degree staple line failure.” “When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. “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. In both of the reported injuries, patients had to undergo a surgical resection of parts of their rectum due to staple failures. The affected staplers are used for creating connections between structures in the gastrointestinal tract during surgical procedures. ![]()
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