About Surgical Staplers
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.
Adverse Events and Product Problems Associated with Surgical Staplers
Each year over the past 5 years there have been 8,000 to 9,000 adverse event reports related to surgical staplers. Ninety-percent were malfunctions, 9% injuries and less than 1% deaths. The most frequently reported device problems were: staples did not form, staplers misfired or failed to fire, and separated suture lines. The most frequently reported patient problems were anastomosis failure, prolonged surgery, bleeding, and infection.