This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields d8, d9, e2, e3, g2(select health professional), 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 5 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's allegation was confirmed.Based on the results of the investigation, it is likely that the device does not work due to a failure of the power unit.In addition, the cause of the failure is considered to be an effect such as repeated operation, but the cause could not be identified.Olympus will continue to monitor field performance for this device.
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