This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The root cause of the reported phenomenon could not be identified.[consideration] it could not be identified.Based on the following information, it was presumed that dirt has entered because a gap was created in the adhesive part of the light guide lens due to physical stress or the like.According to the inspection report of olympus korea, the following were confirmed.There was dirt inside light guide lens.It was found the damaged of the light guide lens.It was found the damage of the object lens.>according to ifu, caution is stated not to apply physical stress.According to the former similar case, it had been presumed that physical stress created a gap in the adhesive part of the light guide lens, and the dirt to enter to there.If additional information becomes available, this report will be supplemented.
|