This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 (thirteen) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: it is presumed that the coiled shaft of cleaning brush contacted with biopsy channel port.Grounds for presumption were the following.- the endo therapy accessories were difficult to contact with biopsy channel port because biopsy valve was attached to the port at procedure.Coiled shaft of cleaning brush may have contacted with biopsy channel port because biopsy valve was detached at reprocessing.The event can be detected by following the instructions for use which state: operation manual, preparation and inspection, inspection of the endoscope: "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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