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/ HF-Resection Electrode [Multiple Model Numbers] [HKMD No.: 220096 & 220097].
According to the TGA, there are complaints where the loop wire at the distal end of the HF resection electrode broke after contact with metal objects, such as other endoscopic equipment, implants, or stents. As a result, fragments can fall inside the patient and must be retrieved.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00531-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Jun 2023