This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.Device manufacturer date was 02-apr-2020 (utc).The device was not returned to olympus for inspection.There was no detailed description from the customer, and it was unknown how inadequately reprocessing was performed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.This phenomenon might have occurred due to a human error.Since it was unknown how inadequately reprocessing was performed and there was no detailed information on the cause, the root cause of the event could not be identified.Olympus will continue to monitor field performance for this device.
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