This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h3 and h6.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.Based on the results of the investigation, physical stress was applied to the insertion section during user handling and caused the coating to peel.3.2 inspection of the endoscope 5.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities." olympus will continue to monitor field performance for this device.
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