Surgical Stapler Malfunctions and Misfires May Result in Debilitating Complications
Surgical staplers manufactured by Ethicon, Covidien and other companies have been linked to reports of permanent and debilitating injuries after design defects caused staple misfires or malfunctions during surgery.
While many individuals first suspect medical malpractice resulted in these surgical complications, financial compensation may actually be available from the manufacturers through a product liability claim.
Contact Saiontz & Kirk, P.A. to determine if you or a loved one may be eligible to pursue a surgical stapler malfunction lawsuit as a result of:
- Internal Bleeding
- Infection or Sepsis
- Fistula Formation
- Internal Tissue and Organ Tearing
- Additional Surgery To Remove Loose Surgical Staples
- Wrongful Death
Surgical Stapler Complications
Surgical staplers have been around since the early 20th Century, but did not gain popularity until the 1950s. They are used to close wounds, both internally and externally, but design defects discovered in recent years have mainly impacted internal surgery staples.
In March 2019, the FDA sent a letter to doctors nationwide, warning that the agency has seen an increase in the number of adverse event reports involving misfires and malfunctions linked to surgical staplers.
According to the agency’s findings, more than 41,000 reports for involving surgical stapler complications were received from January 1, 2011, through March 31, 2018. Those reports included more than 9,000 cases of serious injury, and 366 patient deaths.
Surgery stapler problems may cause procedures to last longer, result in the need for additional surgical procedures and result in severe internal injury or death.
Several large surgical stapler recalls have also been issued in recent years for devices manufactured by Ethicon and Covidien, which may be prone to misfire, be too difficult to fire or pose an infection risk due to sterility problems.
In April 2019, the agency issued a new proposed rule to change the classification for surgical staplers from low-risk to moderate risk medical devices, and also proposed a draft guidance which calls for medical device manufacturers to be more diligent in warning doctors and patients of the potential risks and complications linked to surgical stapler use.
As a result of design defects and failure to provide surgeons with adequate warnings and instructions, the surgical stapler injury lawyers at Saiontz & Kirk, P.A. are reviewing product liability lawsuits against the manufacturers of certain recalled and defective devices.
All claims are pursued under a contingency fee agreement, which means there are never any out-of-pocket costs to hire our law firm and we only receive an attorney fee or expenses if a settlement or recovery is obtained.