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 Boston Scientific EXALT Model D Single-Use Duodenoscope [GTIN: 08714729995746 and 08714729995753; Lot numbers: 31199348, 31574944, 31118201, 31129503, 31265893; Batch numbers: 31712358, 31331654, 31817723] [HKMD No.: 210346].
According to the TGA, the manufacturer is recalling certain batches of the EXALT Model D Single-Use Duodenoscope following an increase in reports of poor image quality due to fluid ingress in the lens. If the user does not have a clear, unobstructed, live endoscopic view, it is anticipated that, in accordance with the warnings in the Instructions For Use, the user will not insert, advance, or further operate the device, as doing so could cause patient injury, such as perforation, bleeding, or tissue damage.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00851-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Sep 2023