Full e1 establishment name: (b)(6) medical center.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found that water tightness was lost due to a pinhole in the bending section cover, the bending tube was damaged, the video cable was buckling, and switch #1 was 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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