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 ESG-410 Electrosurgical Generator [Material Number: WA91307W; Serial Numbers: 102461, 102463, 102529, 102530, 102531, 102532, 102601, 102602, 102750, 102753, 102767] [HKMD number: 210181].
According to the TGA, the manufacturer has identified an increase in complaints related to the ESG-410 generator not powering on. Their investigation has determined that this phenomenon is caused by a failure of electrical components on the generator’s power supply. However, if the device has successfully powered on, it will work within specification.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00490-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Jun 2024