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: 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 "insertion tube coating peeled off" occurred due to user was handling the device, physical/chemical stress was applied to insertion section.The event can be detected/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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