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 Intuitive Surgical, Inc. da Vinci X and Xi EndoWrist Tenaculum Forceps Pitch Cable [Part number: 470207] [HKMD No.: 230483].
According to the TGA, the Tenaculum Forceps contains a pitch cable which controls and facilitates the pitch motion of instrument. Failure of the pitch cable results in loss of motion along the pitch axis. Pitch cable failure may also result in a fragment of the pitch cable and its end-crimp becoming dislodged from the instrument.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00858-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 08 Oct 2024