The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation hasbeen completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and found no detection of the following: e.Coli or other enterobacteriaceae, enterococci, pseudomonas aeruginosa or other non-fermenter, staphylococcus aureus or other hygiene-relevant bacteria, greening streptococci, and germ differentiation.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device evaluation found damaged distal end cap, bending section cover adhesive chipped, insertion tube and protector had buckling, connector plug unit had damaged housing, and angulation control unit was not up to standard once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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It was reported that, the bronchovideoscope tested positive for an unknown number of colony forming units (cfus) of an unspecified microbe.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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