The device was returned to olympus for evaluation and the customer's reported issue of compromised image was confirmed; however, the darkening of the image was not confirmed.During the evaluation, it was determined that: forceps channel port was deformed; image guide bundle had a stain; due to damage on objective lens, a foggy image occurred; due to damage on image guide bundle, the image had a stain; due to a pinhole on channel-tube, water tightness was lost; connecting tube had a dent; due to a cut on angle wire, bending section could not be bent in down direction at all; adhesive around light guide lens was peeled; universal cord has a dent; and scratches were found on multiple components of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon was attributed due to stress of repeated use, external factors, or handling.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
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