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.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Olympus Medical Systems Corp. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE [Product code: Product code: GIF-1TH190] [HKMD No.: 160279].
According to the TGA, the manufacturer has become aware of Ethylene Oxide Gas sterilisation failure due to insufficient channel drying prior to the sterilisation.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00847-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Oct 2023