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 EVIS X1 Video System Center Olympus [Product code: CV-1500; Serial numbers: SN7000617 to SN7353298] [HKMD No.: 220380].
According to the TGA, the manufacturer has received a complaint that the water delivery tube came in contact with the touch panel and the air flow button was unintentionally turned on. This resulted in an adverse event and the patient had a pneumothorax due to the air insufflation during the Peroral Endoscopic Myotomy, POEM procedure. Unintentional contact with the touch panel may result in the activation of unintended functions which could cause patient symptoms or injuries that include abdominal distention, procedure delays, pneumothorax, air embolism, or tissue injury.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00860-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Oct 2023