This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Since the device was not returned, the exact cause was unknown; however, omsc assumed a potential cause as follows.The user operated the angulation function when the distal end was being fixed.The user forcibly twisted the insertion tube.The instruction manual of the subject device states the corresponding method in case of an abnormality.
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