Covidien Surgical Stapler Lawsuit Blames Defective Design for Botched Hernia Repair and Gastric Sleeve Surgery
Surgical Stapler Lawsuit Claims Device Failure Led To Anastomotic Leak, Repeated Surgeries and Ostomy Pouch
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Lawsuit Alleges Surgical Stapler Malfunctioned, Resulting in Bowel Leak and Second Surgery September 24, 2019 Irvin Jackson Add Your Comments Following a gastrointestinal surgery, a California woman indicates she suffered a bowel leak and other complications when a surgical stapler malfunctioned, which was allegedly defective and prone to misfire, according to a recently filed product liability lawsuit. The complaint (PDF) was brought by Lorraine Bonner in the U.S. District Court for the Northern District of California on September 19, claiming an Endo GIA stapler manufactured and sold by Medtronic and it’s Covidien subsidiary was unreasonably dangerous and failed to create staple lines that led to anastomotic leaks. Bonner underwent sigmoidectomy surgery in November 2017, during which an Endo surgical stapler was used internally to connect healthy tissue. After the gastrointestinal procedure, Bonner was slow to regain bowel function and experienced other complications while in the hospital. After a bowel leak was suspected, Bonner was brought back to the operating room about a week later, and a second surgery was required due to the surgical stapler malfunction during the first procedure. Learn More About Surgery Staples Lawsuits Problems with surgical staplers may result in devastating injuries from internal surgery staples. Lawyers review cases nationwide. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Surgery Staples Lawsuits Problems with surgical staplers may result in devastating injuries from internal surgery staples. Lawyers review cases nationwide. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Several months after the Bonner’s complications, Medtronic and Covidien issued an Endo GIA stapler recall in May 2018, with additional products removed from the market in June 2019, due to known defects that may cause the surgical stapler to misfire. “As a result of the defective stapler, Plaintiff was forced to undergo three additional surgical procedures,” Bonner’s lawsuit states. “Plaintiff has since learned that the stapler in question was likely recalled and that the FDA recently reported that surgical staplers, including those manufactured by Defendants, have been responsible for tens of thousands of adverse outcomes attributed to malfunctioning staplers.” In March 2019, the FDA reported that at least 41,000 adverse event reports were filed between January 2011 and March 2018 involving surgical staplers, including 366 patient deaths. Surgical Staples Lawsuits The case is one of a growing number of surgical stapler recall lawsuits filed in recent months, as the FDA is continuing to review design problems associated with a number of devices and how the devices can be made safer for patients. In April, 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. Tags: Covidien, Medical Device Recall, Medtronic, Surgical Stapler Image Credit: | More Surgical Staplers Lawsuit Stories Covidien Stapler Malfunctioned During Surgery, Leading to Tissue Damage and Hospitalization: Lawsuit September 13, 2022 Covidien Surgical Stapler Lawsuit Blames Defective Design for Botched Hernia Repair and Gastric Sleeve Surgery June 9, 2022 Surgical Stapler Lawsuit Claims Device Failure Led To Anastomotic Leak, Repeated Surgeries and Ostomy Pouch February 18, 2022 1 Comments thomas October 4, 2019 i had left knee replaced then they had to do a ligament surg to fix it they i got a infection they 4 more surg to gett right and i still have a infection when they toke the staples out i had a peice of staple still in my knee Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. 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Covidien Stapler Malfunctioned During Surgery, Leading to Tissue Damage and Hospitalization: Lawsuit September 13, 2022
Covidien Surgical Stapler Lawsuit Blames Defective Design for Botched Hernia Repair and Gastric Sleeve Surgery June 9, 2022
Surgical Stapler Lawsuit Claims Device Failure Led To Anastomotic Leak, Repeated Surgeries and Ostomy Pouch February 18, 2022
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