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.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be that the event was caused by stress of repeated use, external factors, or handling.The event can be detected and prevented by following the instructions for use (ifu) which state: operation manual: "chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope".Olympus will continue to monitor field performance for this device.
|