This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.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, olympus presumed that the event caused by external factors, or handling.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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