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 reported phenomenon caused by physical stress / chemical stress / storage environment, etc.-according to the inspection report of olympus china, insertion section was scratched and coating peeled off.-ifu states caution regarding physical stress, reprocessing method and storage environment of device.-according to the former similar case, the event had been seemingly caused by physical stress / chemical stress / storage environment, etc.If additional information becomes available, this report will be supplemented.
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