Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices
MedSun: Newsletter #78, November 2012

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation. Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding.

Additional Information:

Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices. FDA MedWatch Safety Alert. October 26, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325965.htm


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