HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US RSS
 
Subscriber Sign In
 
Today@FDA
FDA Calendar
 
Archived Daily Updates
 
FDA Whistleblower
 
What do you think?
Search our 64,388-story database
Search
Renew subscription










E-mail This to a Friend | Print Format  
     
 
Ethicon Recalls Endo-Surgery Intraluminal Staplers
05/16/2019
 

Ethicon has recalled its Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples due to insufficient firing, which can compromise staple line integrity. According to a recall notice, surgeons use the devices in the “gastrointestinal tract for creating connections between structures (anastomoses) in surgical procedures.”

 

After investigating complaints and returned products, Ethicon confirmed uncut washers in the stapler and malformed staples occur with their intraluminal circular staplers due to the insufficient firing, the notice says. “When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch,” it explains. “Failure to cut the washer suggests complete 360-degree staple line failure. In addition, an investigation of the manufacturing process detected a shift in a process, which occurred in 3/2018 and continued through 3/2019, at which time the line was shut down.”


Post an instant comment on this report here

 
Any copying or electronic transfer without written permission is strictly prohibited and will result
in termination of service and prosecution under the federal Copyright Act.
To gain permission to copy this article log on to http://www.copyright.com.

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com