Deployment failure of Olympus Single Use Repositionable Clip HX-202LR and HX-202UR

A Dear Healthcare Professional Letter has been issued by Olympus Singapore Pte. Ltd. to inform on increased complaints on specific lots of Single Use Repositionable Clip HX-202LR and HX-202UR causing clip deployment failure during clinical procedures. This could lead to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. Patient harms associated with these hazardous situations include absence of treatment (e.g. haemostasis not achieved), prolonged procedure (e.g. extended time to accomplish haemostasis), and unexpected medical interventions (e.g. additional clipping) being required to accomplish therapeutic purposes. Healthcare professionals are advised to immediately cease use, quarantine and return all the affected products. For patients who have been implanted with the affected products, healthcare professionals are advised to exercise clinical judgement based on the type of procedure conducted and assess the patient after the procedure as to whether a re-evaluation is required. 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.