It was reported by the customer, all channels were sampled, and the videoscope tested positive for eleven (11) colony forming units (cfus) of mesophilic organisms.
The issue was found during a routine culture of the scope.
There was no 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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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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