Author Topic: FDA Latest - Class I Medical Device Recall: Ethicon Endo-Surgery, Inc. Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm and the Transtar Circular Stapler Procedure Set (Read 394 times)

pioneer · « **on:** November 20, 2012, 08:04:07 AM »

Class I Medical Device Recall: Ethicon Endo-Surgery, Inc. Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm and the Transtar Circular Stapler Procedure Set

Users have difficulty 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,...

Source: Class I Medical Device Recall: Ethicon Endo-Surgery, Inc. Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm and the Transtar Circular Stapler Procedure Set

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