This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: h3 and h6.Corrected fields: d9 and e1 (reporter phone number).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over two (2) years since the subject device was manufactured.The device not returned to olympus for inspection, therefore the customer's reportable malfunction could not be confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, although the facility staff had acknowledged the frequency of replacement of the water filter, they had managed replacement of the water filter not in accordance with description in the instrument manual but in accordance with the facility¿s own decision.As well the facility staff had acknowledged that disinfection of the water supply piping is required after replacement of the water filter.However, they had practiced disinfection of the water supply piping not in accordance with description in the instruction manual but practiced disinfection once in one or two months in accordance with the facility¿s own decision.Therefore, the subject event was caused by that they had managed equipment by judging that disinfection of the water supply piping after replacement of the water filter was unrequired.The event can be detected and prevented by following the instructions for use which state: instructions, operation manual for oer-6.Section 7.3 replacing the water filter (maj-2317) replace the water filter periodically, at least once in two months to prevent contamination of the rinse water.Warning: after replacing the water filter, be sure to perform the operation described in section 7.4, ¿disinfecting the water supply piping¿ to prevent multiplication of miscellaneous germs and staining inside the water supply pipes.Failure to perform this operation could result in contamination of the equipment piping and/or the scope, preventing effective reprocessing.Replace the water filter at least once in two months.Otherwise, miscellaneous germs and stains in the water may contaminate the equipment and/or the endoscopes and prevent effective reprocessing.Section 7.4 disinfecting the water supply piping disinfection of water supply piping is required in the following cases: before using this equipment for the first time (after installation of the water filter set) immediately after replacement of the water filter whenever bacteria are identified in the water supply piping before using the equipment when it has not been used for more than 14 days.Olympus will continue to monitor field performance for this device.
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