Medical device manufacturer, Covidien, is conducting a voluntary recall for all production lots of Duet TRS™ Universal Straight and Articulating Single Use Loading Units with respect to the use of this product family in the thoracic cavity.
Covidien has received reports of 3 deaths and 13 serious injuries following the application of Duet TRS™ Loading Units in the thoracic cavity. Covidien concluded that Duet TRS™ Loading Units has the potential to injure adjacent anatomical structures within the thorax which may result in life threatening post-operative complications. There have been no reports of adverse event in Hong Kong. The manufacturer advised that users should not use the device in thoracic surgery in both adult and paediatric populations. Users may continue to use the device in other applications.
According to the local supplier, the affected product has been distributed in Hong Kong. For details, please refer to the attachment. If you are in possession of the product, please contact your supplier for necessary actions. |