It was reported that the endoscope reprocessor water filters were replaced once every 2 years instead of once every 2 months, and the user facility staff irregularly disinfected the water supply pipes approximately once every 1-2 months after replacing the water filters.As a result, the scope was insufficiently reprocessed.No patient infections or injuries were reported.
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field: h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.Although the facility staff had acknowledged the frequency of replacement of the water filter, customer 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.In addition, the facility staff had acknowledged that disinfection of the water supply piping is required after replacement of the water filter; however, customer 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.The event can be detected and prevented by following the instructions for use for the oer-6 instruction manual operation manual."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." "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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