Instinct® Plus Endoscopic Clipping Device

Issue

Cook Medical has received 486 complaints of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle. The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire. The clip will extend from the catheter, but it will remain attached to the internal drive wire instead of opening the clip jaws. The clip cannot be opened if this occurs. Corrective actions have been implemented to mitigate the risk of this failure mode. This action is being taken to withdraw products manufactured prior to the implementation of the corrective actions.

What you should do

• Contact the manufacturer if you require additional information.