The customer reported to olympus that during routine microbiological testing, the cystonephrofiberscope tested positive for 1 colony forming units (cfus) of bacillus.All channels were sampled.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
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Updated: h6, h10 this report is being supplemented to provide additional information based on results of third-party testing, the device evaluation, and the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing; additional information regarding the customer's cleaning, disinfection, and sterilization processes was not provided.When olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The event can be prevented by following the instructions for use section below: cyf-5 has a cleaning instruction manual, and the reprocessing method is described in the cleaning instruction manual.Olympus will continue to monitor field performance for this device.
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