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 Corp. Olympus BF-H1100 and BF-1TH1100 Bronchovideoscopes, and Olympus EVIS EXERA III SIF-H190 Small Intestinal Videoscope [Product Codes: BF-H1100, BF-1TH1100, SIF-H190; Multiple serial numbers] [HKMD number: 240282].
According to the TGA, it was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect colour correction data and therefore, specifications were not met. The overall effect on the device is a slightly less intense or faded representation when compared to the desired colour, and in addition the colour blue is slightly shifted to a more purple shade. If the discoloration is noted prior to a procedure (during procedure pre-check), a replacement device may be desired which may potentially result in a minor delay in patient treatment.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00802-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Sep 2024