This supplemental report is being submitted to provide the legal manufacturer's final investigation.Additional information: h6.A review of the device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the "coating of insertion tube peeled off" malfunction would likely be related to stress of repeated use, external factors, or handling.The event can be 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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