This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and the device evaluation.New information added to the following fields: d8, d9, h3, h6, h10.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.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Based on the results of the investigation, a definitive root cause could not be determined, as the event was not reproduced during the device evaluation.Olympus will continue to monitor field performance for this device.
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