User facility personnel stated that the raptor grasping device(s) were actuated prior to use and no issues were noted with the function or operation.The jaws opened and closed as expected.The raptor grasping device(s) subject of the reported event were sent back to steris endoscopy for evaluation.Evaluation results determined that following the removal of the patient's biomaterial from the devices, the raptor grasping device(s) operated properly.The jaws opened and closed with no issues.The device history record (dhr) for the subject lot was reviewed and confirmed the lot was manufactured to specification.A complaint review confirmed this to be an isolated event for the subject device.The instructions for use states, "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." steris offered in-service training on the proper use and operation of the raptor grasping device however, the user facility declined.No additional issues have been reported.
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