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 Intestinal Videoscope Psf-1, Single Use Powerspiral Tube Dpst-1 and Powerspiral Control Unit Pscu [All lots] [HKMD No.: 210274].
According to the TGA, during a procedure on 20 Mar 2023, the intestinal videoscope could not be extracted from the patient. The backward rotation of PowerSpiral withdrawal from the patient was unsuccessful. Manual unscrewing was also unsuccessful. The endoscope had to be surgically removed. It was informed that the patient died on 24 Mar 2023, due to complications from the procedure. Users are advised to immediately cease use of and quarantine the device.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00557-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 Jul 2023