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Tyco US Surgical Stapler

A review by the Food and Drug Administration has linked 112 deaths and 2,180 injuries to surgical staplers. In many cases, the staples failed to close around the patient's tissue or the stapler failed to release the staples resulting in leakage. Among the patients who died, the stapled tissue typically had begun leaking fluid or blood, leading to infection.

Another common problems reported was that the staple gun became stuck in the patients' tissue when it was fired, requiring surgeons to cut away tissue to remove the gun. The problems often prolonged surgery or forced doctors to switch from minimally invasive laparoscopic surgery to open surgery.

FDA reports have showed that some patients required colostomies, in which the intestine is connected to an artificial opening where wastes drain from the body into a bag. The FDA warning follows a report by the Emergency Care Research Institute which printed cautions in its Health Devices newsletter in 2001 about deaths, tearing of tissue, and dangerous leakage of bowel contents. FDA epidemiologist Lori Brown said the agency believes the reports are "the tip of the iceberg." "Because these [devices] are used so often, even if you have a very low rate of problems, it would affect a lot of patients," said Brown.

Tyco International, whose U.S. Surgical subsidiary dominates the stapler market, has been implicated in recent deaths. , says that more than 500,000 surgeries have been performed since 1998 with its latest line of staplers. The FDA reports include more than 3,800 problems, including several deaths, linked to that Endo Gia brand.

If you or a loved one suffered injuries from a Tyco Surgical stapler, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.