This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following fields: h3, h6, h10.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 was identified.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that "coating of insertion tube peeled off" occurred due to stress from use, external factors, or handling.The event can be detected/prevented 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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