Medical device manufacturer, Covidien Private Limited issued a medical device safety alert concerning Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm. The affected product code is 030450 and the affected lot numbers are N2F0563LX, N2F0341LX, N2F0725LX and N2E0605LX.
Covidien has received one report of adverse event where a Single Use Loading Unit contained two staples loading in each cartridge pocket. This condition may result in difficulty firing and removing the device from the application site, which may require medical intervention. According to the manufacturer, no post-operative complications related to this condition have been reported.
The local supplier confirmed that the affected products have been distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 February 2013