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 23 years since the subject device was manufactured.Based on the results of the investigation, it is presumed that coating of the insertion tube is peeled off caused by stress of repeated use, external factors, or handling.However, a definitive root cause of the event could not be specified.The instruction for use states the inspection method associated with the event in "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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