A review by the Food and Drug Administration (FDA) has linked deaths and injuries to a type of surgical stapler. Tyco International, whose U.S. surgical subsidiary dominates the stapler market, has been implicated in deaths from its products. Tyco representatives say 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.

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 problem 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 followed a 2001 report by the Emergency Care Research Institute that printed cautions in its Health Devices newsletter 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.