Ethicon Endo-Surgery Circular Stapler Sets Recalled due to User Difficulty with Firing Stapler Devices

Risk Managers and Surgery healthcare personnel are informed by the FDA that Ethicon Endo-Surgery Circular Stapler Sets are recalled because users face difficulties with firing stapler devices leading to incomplete stapler formation.

Background of Ethicon Endo-Surgery Circular Stapler Sets

Circular Stapler Sets, by Ethicon Endo-Surgery Inc., are used in the surgical treatment of hemorrhoids and prolapse, including applications where circular or semicircular stapling of anorectal tissue is needed.

FDA Alert on Ethicon Endo-Surgery Circular Stapler Sets

FDA’s reason for the recall is that users face difficulties when firing the stapler devices. This can lead to incomplete firing stroke resulting to bleeding, occlusion of the rectal canal, severe pain, rectal wall damage, sphincter dysfunction and sepsis.

The products affected are:

• Ethicon PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH01)
• Ethicon PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code: PPH03)
• Ethicon TRANSTAR Circular Stapler Procedure Set (Product Code: STR10)

The affected products manufacture dates are April 16th, 2011 to July 24th, 2012 and the distribution dates are from April 18th, 2011 to July 23rd, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Ethicon Endo-Surgery Circular Stapler Sets

 “Customers who have purchased the affected devices will be notified by letter through overnight delivery from Federal Express or UPS. All customers should respond to the included Business Reply Form indicating whether they have the affected devices, quantity of affected devices and if they have or will return the product(s).”

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