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According to allegations raised in a product liability lawsuit, design problems with an Endo GIA surgical stapler left her with leaking bowels and the need for multiple additional surgeries after the device malfunctioned.
The complaint (PDF) was filed by Yolanda Carvajal in the U.S. District Court for the Southern District of Texas on January 31, naming the manufacturers of the surgical stapler, Medtronic, Inc. and Covidien, L.P., as defendants.
Carvajal indicates she underwent laparoscopic right hemicolectomy surgery in October 2018, in order to remove potentially malignant tissue from her colon. The procedure involved the use of a Endo GIA 60 mm stapler, which has been linked to reports of malfunction and misfires, although she was unaware of the problems.
Just days after her surgery, Carvajal returned to the hospital suffering progressive fatigue and anorexia. Following additional procedures and surgery, her doctors discovered she was suffering an anastomotic leak near the staple line, due ton a 0.5-1 cm opening where the staples were placed, and appeared to have been disrupted.
As a result of the Endo GIA surgical stapler malfunction, Carvajal indicates she required long-term antibiotic treatment, intraabdominal drains, the placement of an enteral tube, and in January 2019 underwent a failed colonscopic attempt to clip the leak site, as well as further procedures.
The lawsuit notes that Endo GIA staplers, like the one used during her surgery, were subject of recalls in May 2018 and June 2019, including surgical staplers distributed between April 2014 and April 2019.
“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 thousands of adverse outcomes attributed to malfunctioning staplers,” the lawsuit states.
The lawsuit notes the defendants used FDA exemptions to avoid reporting non-fatal stapler injuries to the agency, hiding the true risks of using the devices from the medical community and patients. It notes that while only 84 stapler injuries or malfunctions were reported in 2016, there were actually nearly 10,000 surgical stapler malfunctions reported in a hidden database, by the FDA’s own admission.
In March 2019, the FDA indicated that at least 41,000 adverse event reports involving surgical staplers were filed between January 2011 and March 2018, including 366 patient deaths. As a result of the problems, the FDA proposed new rules and guidelines designed to make surgical staplers safer in April 2019, and decided to classify the products as moderate risk medical devices, as opposed to low-risk devices.
The new classification requires more stringent pre-market approval for new surgical staplers and forces 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 warns 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.
Carvajal’s complaint joins a growing number of surgical stapler lawsuits filed by individuals nationwide who suffered serious injuries or who lost loved ones due to stapler malfunctions.