The subject device was received and evaluated.Device evaluation and inspection, service repair noted the following findings: device inspection noted tearing on curved rubber due to external factors.The curved rubber (insertion part) has fallen off.Watertightness is not maintained due to the tearing of the curved rubber.Liquid leakage is observed on the lg (light guide) connector.The insertion part serpentine is crushed due to an external factor.Furthermore, the following findings during inspection were noted on the device: scratches are found on the surface of the lg cover , operation part, eyepiece, grip, forcep cap, angle lever, u/ud (up/down) plate, universal cord, fixed ring, scope connector, up/down fixing lever, light guide connector due to external factor.Investigation is ongoing.This report will be supplemented accordingly following investigation.
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress, handling, or other issues.Olympus will continue to monitor field performance for this device.
|