This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 18 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the defect was caused by stress of repeated use, external factors, or handling.However, olympus could not identify a definitive root cause of the event.The instructions for use states the inspection method associated with the event in "3.2 preparation and inspection of the endoscope" chapter 3 preparation and inspection.Olympus will continue to monitor field performance for this device.
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