Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Olympus Medical Systems Corporation. has issued a medical device safety alert concerning its Endoeye Flex 3D Deflectable Videoscope [LTF-190-10-3D] [HKMD No.: 130448].
The manufacturer is writing to inform users of a revised, corrected repossessing manual for the LTF-190-10-3D DEFLECTABLE VIDEOSCOPE (“LTF-190-10-3D”) is now available. The manufacturer identified the wrong glutaraldehyde (GA) concentration in the reprocessing manual. The reprocessing manual incorrectly stated 2 – 35% GA concentration. The corrected GA concentration is 2 – 3.5% GA concentration. The manufacturer is providing an Addendum which contains the corrected disinfectant concentration of GA in the reprocessing manuals.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Nov 2022