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Model Number CF-HQ190L |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that during reprocessing, the colonovideoscope tested positive for less than 1000 colony forming units (cfus) of escherichia coli, 1 cfu of micrococci luteus, 1 cfu of streptococcus and less than 50 cfus of citrobacter freundii.The suction channels and insufflation channel 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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Manufacturer Narrative
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The suspect device has not yet been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the suction and insufflation channels of the scope were cultured and found less than 1000 colony forming units (cfus) of escherichia coli, 1 cfu of micrococci luteus, 1 cfu of streptococcus and less than 50 cfus of citrobacter freundii.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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Search Alerts/Recalls
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