Urgent medical device recall for Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology

Covidien Pte Ltd would like to notify healthcare professionals of the voluntary recall of selected lots of Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology due to the potential for improper welding of the yellow staple guide to the instrument. This issue was identified by Covidien during a recent in-process quality testing at their manufacturing facility. There have been no reports of serious injury related to this issue. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. Healthcare professionals are advised to quarantine and return all units of the affected medical devices to Medtronic Pte Ltd. Please refer to the letter for details.

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.