This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field d8, d9, h3, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, the front panel indicators did not light up, the screen went black, and an alarm was generated after startup, likely due to a faulty printed circuit board.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
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