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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% were with injuries and less than 1% deaths. The most frequently
reported device problems were: staples that 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.
For additional information, please go to:
http://www.fda.gov/cdrh/surgicalstapler/
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