This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: e1, g2 additional information added to field h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it was presumed that event caused by stress from repeated use, external factors, or handling.However, a definitive root cause could not be determined.The instruction manual states the detection method associated with the event in "chapter 3 preparation and inspection 3.3 inspection of the endoscope".Olympus will continue to monitor field performance for this device.
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