This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation. new information added on field: h6.Correction on fields: b5, d9, e1, e2, e3 and g2.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.The device was evaluated by a third party and the customer's complaint was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that pressure was insufficient due to a failure of the main board.Therefore, it is presumed that the problem is caused by the main board failure.Olympus will continue to monitor field performance for this device. .
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