The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, switch box scratched, air/water-cylinder has no color, suction-cylinder has no color, due to a crack on angle rubber, insulation resistance value at distal end does not meet the standard value, distal end cover chipped, and connecting tube cut.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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.Based on the results of the investigation, the root cause of the event was unable to be identified.The foreign object could not be identified.It is likely foreign objects remained in the channel due to the user's failure to properly reprocess the scope.If handled according to the instructions for use (ifu) below, the user may be able to detect the event: -inspection of the air-feeding function.-inspection of the objective lens cleaning function.-inspection of the suction function.Olympus will continue to monitor field performance for this device.
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