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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Covidien Stapler Malfunctioned During Surgery, Leading to Tissue Damage and Hospitalization: Lawsuit Lawsuit indicates design defects caused stapler to malfunction, resulting in numerous injuries, long-term hospitalization and weeks of rehabilitation and home health care September 13, 2022 Irvin Jackson Add Your Comments Medtronic and it’s Covidien subsidiary face a product liability lawsuit filed by a North Carolina woman, who indicates she was left with severe injuries when a surgical stapler malfunctioned, resulting in tissue damage and the need for additional surgeries. The complaint (PDF) was filed by Kimberly Bell in Massachusetts federal court on September 9, indicating that an Endo GIA 45mm stapler with Tri Staple Technology malfunctioned during surgery, causing a “tear” in the surgical area, leading to prolonged hospitalization and extensive medical care. The case joins a growing number of surgical stapler lawsuits being pursued against Covidien and other manufacturers, each raising similar allegations that design defects caused the devices to misfire, fail to fire or issue malformed staples, which can cause devastating internal injuries and organ perforations. 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 The lawsuit indicates Bell underwent a laparoscopic biliopancreatic diversion and hernia repair in September 2019, at which time the Covidien stapler malfunctioned. Following additional surgical procedures to repair the damage, Bell indicates she suffered nausea, vomiting and hypertension, followed by shortness of breath and worsening abdominal pain, as well as poor urinary output. She then became hypotensive, suffering from low blood pressure. She was diagnosed as suffering an anastomotic leak due to a tear at the apex staples, measuring 5 mm. “This anastomotic leak led to Ms. Bell’s development of acute respiratory failure and pulmonary edema leading to septic shock,” the lawsuit states. “After her procedure on September 14, 2019, Ms. Bell was transferred to the critical unit for medical intensive care and vent management, Ms. Bell was on a ventilator for seven (7) days. She required several liters of Lactated Ringer’s solution and developed acute kidney injury which required her to start intermittent hemodialysis.” Later that month she suffered atrial fibrillation, and spent a total of 30 days in the hospital, including two weeks in critical care and another week on a ventilator. She was then released to a rehabilitation facility for another two weeks, followed by about two weeks of home health care. Surgical Stapler Problems In March 2019, the FDA reported at least 41,000 adverse event reports involving surgical stapler failures were filed between January 2011 and March 2018, including 366 patient deaths. However, it appears that those reports did not include all problems linked to the devices. As part of an effort to make surgical staplers safer, the FDA issued new rules and guidelines for Covidien and other manufacturers, and has to reclassified staplers as Class II surgical devices, which now requires any new surgical staplers to undergo premarket review before getting FDA approval. The change of surgical staplers from class I medical device (general controls) to class II medical devices (special controls) has been anticipated for several years, and does not affect the classification of the staples themselves. However, it would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions. Tags: Atrial Fibrillation, Covidien, Hernia, Medtronic, Pulmonary Edema, Surgical Stapler More Surgical Staplers Lawsuit Stories 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 Covidien Surgical Stapler Class Action Lawsuit Filed Over Life-Threatening Infections in Canada January 17, 2022 1 Comments Cynthia April 6, 2024 Covidien 28 mm stapler recall? 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 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
Covidien Surgical Stapler Class Action Lawsuit Filed Over Life-Threatening Infections in Canada January 17, 2022
Depo-Provera Shots Triple Brain Tumor Risks Compared to Birth Control Pill: Study (Posted: 2 days ago) Canadian researchers say receiving Depo-Provera injections for more than a year triples the risk of brain tumors compared to women who take birth control pills. MORE ABOUT: DEPO-PROVERA LAWSUITDepo-Provera Lawsuit Pre-Settlement Funding and Loans Must Be Disclosed Under Court Order (07/09/2025)Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (07/02/2025)Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)
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