Johnson and
Johnson has recalled more than 157,000 surgical stapler devices and accessories
used in hemorrhoids treatment procedures due to potential malfunctions that
pose a serious safety risk. The recall is a Class 1 recall, the most serious
classification of recalls. Class 1 recalls are only issued when a defective
medical device is likely to cause serious health problems or death.
These
products are commonly referred to as “Staple Accessory Kits” or “Internal
Hemorrhoid Staples”. They are manufactured by J&J's Ethicon Endo-Surgery division.
The
recalled products are:
Transtar Circular Stapler Procedure
Set
Proximate HCS Hemorrhoidal Circular
Stapler and Accessories
Proximate PPH Hemorrhoidal Circular
Stapler and Accessories
The FDA
issued a recall based on issues related to the firing of the device which may
result in incomplete staple formation. An incomplete staple formation is
similar to when you attempt to staple too many pieces of paper together and the
staple does not puncture through all of the pieces and does not fasten
correctly.
Failure of
an incomplete staple formation can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis,
bleeding, occlusion of the rectal canal, and splitting of rectal wall staple
line and bleeding.
The affected
products were manufactured and distributed between
April 2011 and July 2012.
J&J
said its Proximate HCS hemorrhoidal circular stapler and accessories with
product code "PPH01" have been discontinued in the U.S. However, the
Proximate PPH stapler remains available.
Pittman, Dutton
& Hellums, P.C. is currently investigating “Staple Accessory Kit” injury
claims. If you or a loved one were injured as a result of this product, please
contact Booth Samuels at 1-866-515-8880
or by email at
booths@pittmandutton.com.