Ethicon Recalls Colorectal Staplers
Devices' difficult use created post-op complication risks.
Published: October 30, 2012
Ethicon Endo-Surgery has initiated a recall of 3 surgical staplers used in hemorrhoid treatment, prolapse repair or other procedures requiring the circular or semicircular stapling of anorectal tissue.
According to the FDA, some users of the devices have reported difficulty in firing them. An incomplete firing process can result in improperly formed staples, which can result in patients suffering post-operative pain, bleeding, sepsis, rectal wall damage, rectal canal occlusion and/or sphincter dysfunction.
The staplers at issue are all lots of the following models, manufactured and distributed between April 2011 and July 2012:
- Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm
- Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm
- Transtar Circular Stapler Procedure Set
Users should contact Ethicon Endo-Surgery at (800) 873-3636 or email@example.com for further information.
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