Occurrence of uncut washers and malformed staples with affected lots of Ethicon Intraluminal Staplers
Healthcare professional
Medical devices
9 April 2019
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Johnson & Johnson Medical Singapore would like to inform healthcare professionals on a voluntary recall of affected lots of Intraluminal Staplers (ILS) due to occurrences of uncut washers and malformed staples with their ILS, which can compromise staple line integrity. If a problem with the staple line is not adequately addressed or is not recognised, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, haemorrhage, or haemorrhagic shock. Nonetheless, Ethicon recognises that there is a worldwide supply issue with ILS and alternative products may not be available. Healthcare professionals may choose to continue using these affected products if they do not have alternative product available but are reminded to adhere to recommendations specified in the letter. 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.
