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] based on the following information, it was presumed that the cause of the reported phenomenon was dirt had 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 results of olympus india, dirt inside the light guide lens was confirmed.According to ifu, caution is stated not to apply physical stress.According to a similar former case, it had presumed that the cause was that a gap was created in the adhesive part of the light guide lens due to physical stress, etc., and dirt entered.If additional information becomes available, this report will be supplemented.
|