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 Corporation bronchoscopes, tracheal intubation scopes and airway mobile-scopes [Multiple model numbers] [HKMD No.: 140190, 140191].
According to the TGA, the manufacturer has received a complaint that upon using Olympus bronchoscope model BF-1TH190 with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. The investigation results revealed that the incident occurred due to the endoscope’s insertion tube outer diameter being too large for the connector.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00612-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 Jul 2023