This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and found that the reported phenomenon was not duplicated, also there was no abnormality on the exterior.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based upon the information from the user, there was the possibility that this phenomenon was attributed to the inappropriate setting of the drain hose, or effects of poor water discharge due to too little water in the reprocessing basin.If additional information becomes available, this report will be supplemented.
|