Tyco Surgical Stapler
Tyco surgical staplers are one of the most popular models of surgical staplers sold on the medical device market. Surgical staplers and clip appliers are complex mechanical medical devices that have been on the market for years and are mature in their technology. These devices are used in gastrointestinal, gynecologic, thoracic, and many other surgeries to remove part of an organ (resection), to cut through organs and tissues (transection) and to create connections between structures (anastomoses). The benefit of using these devices allows for more complex procedures and shorter surgical procedure time.
Each year there are 8,000 to 9,000 adverse event reports related to surgical staplers. Between November 14, 1994 and July 1, 2001 the FDA received 112 surgical stapler adverse event death reports. The death reports involved staplers that did not fire or staples that did not form properly. There are also reports of suture line separation from staples that did not form or fell off. Physicians and other health care professionals should be aware of problems with surgical staplers and report deaths, serious injuries, or malfunctions to the manufacturer or distributor. A study is underway to characterize deaths, injuries, and malfunctions.
The following staplers were involved in the reported adverse events:
- Endoscopic linear cutters
- Articulating linear staplers
- Curved intraluminal staplers
- Multiple clip appliers
- Disposable autosuture
The majority of the events occurred during gastrointestinal surgeries (65%) or plumonary procedures (19%). Other surgery sites involved the cardiac, circulatory, hepatic and nephrotic systems, and sites unspecified. However, these reports do not establish a causal link between the reported device and adverse events. The reports provide a signal to manufacturers, regulators, and device users to help identify potential problems with surgical staplers. If you or someone you loved has been harmed by a Tyco surgical stapler or any other form of surgical stapling medical device, consult our offices today.
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