Urgent medical device recall for Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology
Healthcare professional
Medical devices
8 May 2018
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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.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.
