Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Kwart Retro-Inject Ureteral Stent Set and Salle Intraoperative Pyeloplasty Stent Set. The affected devices are identified as the following:
The manufacturer has identified that the Instructions for Use (IFU) do not contain sufficient warning associated with use of these products. The IFUs are currently in process of being updated and will include the following warning:
"Formation of knots in multi-length stents may occur. This may result in injury to the ureter during removal and/or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encountered during attempts at removal."
It is to inform users of the potential for stent knotting to occur and its possible outcomes.
Users should understand that stent knotting is a potential complication associated with use of the affected product and should be considered if significant resistance is encountered during attempts at removal. If user has product in inventory, users may continue to use these products. The manufacturer is not requesting product be returned.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 25 April 2019