This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields h3 and 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 were identified.Based on the results of the investigation, it is likely the following led to the malfunction: it is assumed that the defective item is due to stress from use, external factors, or handling.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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