This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h3, 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 was identified.Based on the results of the investigation it is likely the image guide tube had a coat peeling due stress of repeated use, external factors, or handling.The event can be prevented by following the instructions for use which state: "3.3 inspection of the endoscope 4 inspect the external surface of the entire insertion section, including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects." olympus will continue to monitor field performance for this device.
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