This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and it was confirmed that the subject device alarmed and powered off.However, the defective lighting of the front panel led was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it was identified that the device alarming and powering off was due to a failure of the mainboard.However, the root cause of these defects could not be determined.Moreover, since the defective lighting of the front panel led was not confirmed, the root cause of the failure could not be determined.This supplemental report includes a correction to b5 and g2 to provide information that was inadvertently not included in the initial medwatch.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.
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