Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
Authorities have posted medical device safety alerts concerning Olympus Medical Systems Corp Evis Exera III Duodenovideoscope [Model Number: TJF-Q190V; UDI-DI: 04953170405563; All Serial Numbers; All Lots].
According to Health Canada, the manufacturer is aware of recent reports of infections and positive cultures and inquiries from the United States Food and Drug Administration regarding these reports. The manufacturer is reminding users to closely follow reprocessing instructions, including periodic inspections by the manufacturer, and informing users about an updated manual intended to improve comprehension of existing steps. The manufacturer is reminding users that the use of a damaged or contaminated endoscope can present an infection risk to patients.
For further information, please visit
Health Canada: https://recalls-rappels.canada.ca/en/alert-recall/evis-exera-iii-duodenovideoscope
The United States Food and Drug Administration: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92703
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Oct 2023