Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.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 on the report of olympus korea and thing which it was found the insertion tube of the subject device was damaged at the incoming inspection, omsc surmised there was the possibility this phenomenon was attributed to the occurrence of the insertion tube damage.The reported phenomenon might have occurred as soon as the insertion tube damage was happened.If additional information becomes available, this report will be supplemented.
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