This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The following were confirmed in the evaluation of the omsc.- the insertion tube is cut at about 300 mm from the distal end.- the insertion tube was crushed at about 180 mm to 200 mm from the distal end.- there was no rust and wear on the parts inside the insertion tube (metal wire, metal frame, etc.), and there were no signs of metal fatigue and deterioration.As reported in the initial report, this event occurred when the user facility inserted the subject device into the patient's urethral stricture site and the insertion tube was deformed.The deformation of the insertion tube is likely due to applying an excessive force to the device in order to pass the device through the urethral stricture site.
|