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Model Number CYF-VH |
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 01/30/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.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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Event Description
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It was reported that, during reprocessing, the videoscope tested positive for 1 colony forming unit (cfu) of bacillus spp.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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Manufacturer Narrative
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This report is being supplemented to provide additional information based on results of third-party testing, the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation and the legal manufacturer's final investigation.Olympus provided the following results of the culture testing performed at the third-party labs: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu:< 1.Bacterial identification:n/a.Upon review of the customer provided facility cleaning disinfection and sterilization practices (cds), no obvious deficiencies in the device reprocessing were found.The device was evaluated and no abnormalities were found that could have led to positive culture.A review of the device history record found no deviations that could have contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing, however, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The event may be prevented by following the instructions for use below: cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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