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 10 years since the subject device was manufactured.Based on the results of the investigation, the peeled coating was likely caused by stress of repeated use, external factors, or handling; however, a definitive root cause could not be determined.The event can be detected by following the instructions for use: ¿chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope".Olympus will continue to monitor field performance for this device.
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