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.
Health Canada has posted a medical device safety alert concerning Olympus Winter & Ibe GmbH Electrosurgical Generator, ESG-410 [Model or catalog number: WA91327U] [HKMD No.: 210181].
According to Health Canada, Olympus is conducting this medical device recall after identifying an increase in complaints indicating an occurrence of system error e1226 "could not write to audio buffer" during procedures using the ESG-410 (Sep). This error is a high priority alarm which triggers an automatic reboot of the device, which may lead to a delayed or interrupted procedure until the reboot is completed. Rebooting is a safety measure to put the generator back into safe operation. After the reboot, the procedure can be continued. Olympus has developed a software update that prevents this system error e1226 from unnecessarily occurring.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/electrosurgical-generator-esg-410
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Oct 2024