This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Since the subject device was not returned, the exact cause was unknown; however, omsc assumed a potential cause as follows.The user forcibly pushed the device into the patient body with the bending section bent and it caused the failure.The instruction manual of the subject device states the corresponding method in case of an abnormality.
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