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 Winter & Ibe GmbH ENDOEYE HD II [Product codes: WA50040A and WA50042A; All serial numbers] [HKMD No.: 220133].
According to TGA, the manufacturer has become aware of complaints, including adverse events related to pink or green colouration of the image, including cases with reported delays of treatments and/or prolonged surgery. The imaging colour is an important factor affecting visualisation in laparoscopic procedures to recognise relevant tissue areas for treatment. When an image discolouration is detected prior to a procedure, it is expected that the device will require replacement, leading to a delay in patient treatment. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery, and due to potential visual impacts mucosal injury or bleeding may occur.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00935-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Nov 2023