This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: h8 additional information added to field h3 and h6.Based on the results of the investigation, it is presumed that the event occurred due to stress of repeated use, external factors, or handling.However, a definitive root cause could not be determined.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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