Full e1 establishment name: (b)(6) hospital.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the electrical contact of the video connector was corroded, there was image noise due to a damaged charged coupled device (ccd) unit, the bending section cover adhesive was chipped, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, and a foggy image and black dots on the image occurred due to damage on the ccd unit.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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