The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the bending section cover leaked due to a cut, the light guide prong and tube were leaking, the control unit label was missing, the light guide tube was dented, the control knobs were heavy and grinding, angulation was reduced, and multiple parts of the scope were non-olympus parts.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The foggy image was likely due to water invasion and moisture adhering to the objective lens; however, 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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