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 bending section cover adhesive was chipped, the bending angle in the up direction and the return angle from the bending of the bending section did not meet the standard value due to wear of the angle wire, the objective lens was dirty, the universal cord was dented, the light guide connector was stained, the video connector case was cracked, 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 a definitive root cause of the foggy image could not be identified, it was determined that stress of repeated use, external factors or handling may have caused the damage to the objective lens, which resulted in the reported event.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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