The device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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It was reported that, during reprocessing, the uretero-reno fiberscope tested positive for 4 colony forming units (cfus) of moraxella and brevundimonas species.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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