The device subject of this complaint is not available for return to steris endoscopy for evaluation.Without the return of the complaint device, the complaint cannot be confirmed, and the cause of the reported issue cannot be determined.The user facility declined steris' offer of in-service training.The instructions for use packet (ifu 732260) states that the following conditions may not allow the device to perform properly: "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage, do not use this product and contact your local product specialist.Attempting to advance the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath." no additional issues have been reported.
|