This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h6 and h3.Corrected date: g3 of the initial medwatch aware date should be april 12, 2024.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, it was presumed that the coating in the insertion section had peeled off due to physical stress.However, the definitive root cause could not be determined.The event can be detected by following the instructions for use which state: 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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