Staplers used in hemorrhoid surgeries and other procedures involving the rectum have been recalled because of a defect that can cause serious health problems, some of which can lead to death.
The recall affects involves the 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.
The devices are used in the surgical treatment of conditions such as prolapse and hemorrhoids, the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects, and obstructed defecation syndrome. The devices deliver either a single staple firing or multiple staple firings, depending on the model used.
The recall was initiated because users have reported having difficulty firing the stapler devices, which has resulted in incomplete firing stroke and incomplete staple formation. Failure to complete the firing stroke of the stapler can cause severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Poor staple formation can also cause dehiscence of the rectal wall staple line and bleeding.
The recall is classified as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.
Health care professionals and patients should report any adverse reactions or quality problems they experience with these products to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.