This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.The device was returned to olympus for inspection, and the reportable malfunction found was coating peeled off.Based on the results of the investigation, it is likely the following led to the malfunction: we presume physical stress as cause of the suggested event.The event can be detected by following the instructions for use: 3.2 inspection of the endoscope 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor field performance for this device.
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