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 the customer's reportable malfunction was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and although we could not specify the root cause of the suggested event, it is likely the defect was caused by stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.
|