A user facility reported to olympus that water entered the device when a tube, used for flushing, got too close to the device.The problem, as reported to olympus, was identified during preparation for use.There was no end user or patient injury, associated with the problem, reported to olympus.
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This report is being supplemented to provide additional information based on the legal manufacturer's 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 legal manufacturer's investigation, the root cause of the reported event could not be identified, nor the event be reproduced/confirmed.Olympus will continue to monitor field performance for this device.
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