His supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 9 years, since the subject device was manufactured.Since, the subject device was not returned to legal manufacture.The reported event cannot be confirmed, neither the condition of the device.Therefore, the root cause, neither the cause of occurrence could be determined.Olympus will continue to monitor field performance for this device.
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