The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the white glue at the distal end body joint was missing, the bending section cover was cracked, the light guide lens was cracked, and the video connector case and printed circuit board were cracked.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; 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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