The concerned unit was returned to the olympus repair center.During the repair inspection/testing, the customer¿s reported e006 error could not be reproduced.However, the units recorded error log shows the multiple errors including e002 (short circuit instrument electrodes coming in contact with each other), e202 (insufficient ne contact) and e006 (no conductive fluid detected).The inspection noted the unit has an old lvps cable.Also, the software is version is an older type.The repair history shows the unit was last serviced via repair in (b)(6) 2018.The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section b5 was corrected with information that was inadvertently omitted from the initial report.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 definitive root cause of error e006 could not be determined.Error e006 may be caused by increased electrical resistance between two electrodes due to poorly or insufficiently plugged contacts on the conveyor or connecting cable, defective contacts, or growing tissue deposit on the electrode.Olympus will continue to monitor field performance for this device.
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