The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the image was foggy and the focus was not obtained due to damage on the charged coupled device (ccd) unit, water tightness was lost due to a pinhole on the bending section cover, water tightness was lost due to a shaved venting connector of the light guide connector, the bending section cover adhesive was chipped, the angulation lever was deformed, the light guide lens was chipped, the video connector was cracked, the indicator on the light guide connector was not correct, and multiple parts of the scope were scratched.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although the foggy image was confirmed through evaluation of the device and the damaged objective lens was likely due to stress of repeated use, external factors, or handling, a definitive root cause of the foggy image could not be determined.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the instructions for use (ifu).If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.
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