Lawsuit Filed After Covidien Stapler Broke During Surgery, Causing Severe Complications
Medtronic faces a product liability lawsuit brought by a Texas couple, after a Covidien surgical stapler broke during a surgical procedure, resulting in an abdominal leak, infection, and the need for a colostomy.
The complaint (PDF) was filed by William Bruce Jones and his wife, Kathleen, in the U.S. District Court of Minnesota on December 17, alleging that Medtronic and its Covidien subsidiary manufactured defective and unreasonably dangerous staplers, which malfunctioned and failed when used during a surgical procedure in December 2019.
Jones indicates that while he was undergoing a sigmoidectomy, colorectal anastomosis, repair of colotomy and intraoperative colonoscopy, the surgeons used a Covidien EEA Circular Stapler with DST Series Technology 28 mm- 4.8 mm and a EEA Circular Stapler with DST Series Technology 31 mm- 4.8 mm during the anastomosis. However, the first Covidien stapler broke during surgery, when a pin popped out of place. As a result, the surgeon had to remove the broken stapler and use a second Covidien stapler to finish the procedure. The doctor noticed a leak from the anastomosis caused by the removal of the first stapler and had to repair it with sutures, leaving Jones with serious and on-going injuries.
“Three days later, when Plaintiff was still recovering from his surgery, he became tachycardic, began vomiting a greenish-black liquid, and his stomach became tight and distended,” the lawsuit notes. “He was rushed back into surgery, where his surgeons found that his anastomosis had partially dehisced. The surgeons found an approximately 5-mm defect and significant contamination around the area. Due to the size of the defect, Plaintiff’s surgeons were forced to fit Plaintiff with a colostomy.”
The case joins a growing number of similar surgical stapler lawsuits filed in recent years against Covidien and other manufacturers of products that have been plagued by recalls and problems.
In March 2019, the FDA reported that at least 41,000 adverse event reports involving problems with surgical staplers were filed between January 2011 and March 2018, including 366 patient deaths. The next month, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and to classify them as moderate risk medical devices.
As part of an effort to increase the safety of surgical staplers, the FDA announced last year that it had finalized new rules and guidelines for manufacturers, including a decision to reclassify 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.
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