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 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 d8, 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, the reprocessing for the endoscope was insufficient since the filter has not been replaced.However, a definitive root cause could not be determined.The event can be detected and prevented by following the instructions for use which state: "instructions, operation manual for oer-6 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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