This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation. new information added on field: h6.Correction on field: d10 (added therapy date).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured. based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the user did not read instructions for use (ifu) carefully, incorrectly managed water filter replacement and used the filter even after its replacement period has expired.The event can be [detected/prevented] by following the instructions for use which state: chapter 8 replacement of consumable items -8.4 replacing the water filter (maj-824 or maj-2318) to prevent contamination of the rinse water, the water filter should be replaced every month when the prefilter is not used or every six months when the prefilter is used.Warning ·replace the water filter at least every month when the prefilter is not used or every six months when the prefilter is used.If the water filter is not replaced regularly, the performance of the water filter drops, and insufficient elimination of microorganisms in the water may cause contamination of the reprocessor piping.As a result, the reprocessing of endoscopes will be insufficient.Olympus will continue to monitor field performance for this device. .
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