Based on the results of the investigation, the foggy image was likely caused by breakage of the objective lens and a damaged charged coupled device unit; however, a definitive root cause could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.This issue is addressed in the instruction for use (ifu): -"chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system¿ describes the methods for inspection on the suggested event.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
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