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 Xi/X Instrument Arm Drapes [Lot numbers: DM3223602; Part number: 470015-07] [HKMD No.: 220174].
According to the TGA, the manufacturer is informing users that a specific lot (DM3223602) of da Vinci Xi/X Instrument Arm Drapes (Part 470015-07) has an incorrect expiration date listed on the brown outer shipping box. The incorrect expiration date on the brown shipping box is 30/09/2044, while the correct expiration date on the inner carton pouch labels is 30/09/2024. This does not impact functionality or sterilisation of affected product.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00815-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Sep 2023