The subject device has been received and is currently in the evaluation process.
The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.
However, if additional information becomes available this report will be supplemented accordingly.
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It was reported by the customer, after a microbiological routine culture on the uretero-reno fiberscope, an unexpected contamination was detected.
There was no reported 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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This supplemental report is being submitted to provide additional information from the reporter and the cleaning, disinfection, and sterilization (cds) checklist performed by the customer.
The cleaning, disinfection, and sterilization (cds) was performed by the customer.
There was no patient infection.
The sampling was routine.
The automatic endoscope reprocessor (aer) was sampled/cultured, however the test report was not available.
The flushing of the air/water channel, auxiliary water channel, and forceps elevator wire channel were precleaned without detergent.
The instrument/suction channel, instrument channel port, and the distal end/areas around the elevator were manually cleaned with olympus bw-400b single-ended cleaning brushes.
The scope was not manually disinfected.
The scope was however disinfected with anioxyde 1000 disinfectant every procedure.
The scope was not sterilized.
The maintenance was performed by olympus.
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