The FDA has announced a voluntary global recall of more than 157,000 Ethicon surgical staplers, due to problems with incomplete firing strokes that may cause faulty staple formation, potentially resulting in painful and severe internal complications for the patient.
An Ethicon surgical stapler recall was first announced in August, after reports surfaced where surgeons experienced problems that required them to abandon use of the device during surgery due to difficulty firing it.
On October 26, the FDA indicated that the action was categorized as a Class I recall for the Ethicon Endo-Surgery circular staplers, due to the potential risk it may pose for consumers.
These faulty medical devices are used in the surgical treatment of prolapse and hemorrhoids, where circular or semicircular stapling of anorectal tissue is needed.
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.
The recall affects the following products:
- 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 recalled surgical staplers were manufactured by Ethicon, a subsidiary of Johnson and Johnson, between April 16, 2011 and July 24, 2012 and distributed from April 18, 2011 to July 23, 2012.
The initial Ethicon Endo-Surgery stapler recall was announced in August following complaints that the surgical staple guns were too hard to fire. In one case, a surgeon gave up trying to use the stapler mid-surgery due to frustration and an inability of the device to function
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.