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Model Number CYF-5 |
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 03/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during reprocessing, the biopsy channel, the air/water channel, and the suction channel from the cystonephrofiberscope tested positive for 1 colony forming unit (cfu) of bacillus pumilus and 1 cfu of staphylococcus haemolyticus.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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D8 was inadvertently selected.The device evaluation is ongoing.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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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the 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 result of the culture test, performed at the third-party labs: sampling date: apr.12, 2024.Sampling from: all channels.Colony forming units (cfus): <1 cfu.Bacterial identification: none.The cleaning disinfection and sterilization (cds) practices of the user were reviewed and there were no reported deviations from the instructions for use (ifu).The device was evaluated and no abnormalities were found that could have led to the positive culture.A review of the device history record found no deviations that could have caused or 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.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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