This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following 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 that the suggested event occured due to stress of repeated use, external factors, or handling.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: 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.
|