This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.In addition, found a red mark on the probe's tip, more likely blood stains were found.Based on the results of the investigation, it is likely the following led to the malfunction: the most probable cause of the identified failures is cause traced to component failure, which is expected or random component failure without any design or manufacturing issue.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
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