Based on the results of the investigation, the foggy image was likely caused by breakage of the objective lens; 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.The issue is addressed in the instructions for use (ifu): -"chapter 3 preparation and inspection, 3.6 inspection of the endoscopic system" describes the methods for inspection on the suggested event.E1/establishment name: (b)(6) hospital, a local independent administrative corporation.Added here due to character limitation in respective field.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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