Steris endoscopy has requested additional information regarding the reported event and for the device to be returned for evaluation if available.The instructions for use includes the following statements, "actuate the device by moving the slider on the handle back and forth to confirm that the grasping jaws open and close smoothly.If the unit does not function properly, or there is evidence of damage (e.G.Bends, kinks, misshapen jaws, misaligned jaws, exposed wires) do not use this product and contact your local product specialist.Do not use excessive force on the handle and do not coil the catheter outside of the endoscope.Excessive force or coiling may damage the device or damage the endoscope and may result in accidental injury to the patient or clinician.The following conditions may cause the device to function improperly: advancing 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.Actuating the device when the handle is at an acute angle in relation to the sheath." the device history records for both lots were reviewed and confirmed the devices were manufactured to specification.A follow-up report will be submitted should additional information become available.
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Us endoscopy requested the devices subject of the event to be returned for evaluation; however, the distributor reported that the customer discarded the devices.Without the return of the devices, the cause of the reported issue cannot be determined.No additional issues have been reported.
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