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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 01/04/2024 |
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 been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The customer provided the cleaning, disinfection, and sterilization process.No precleaning steps were identified.During manual cleaning, the detergent used was salvanious ph 10.The distal end / areas around the elevator were brushed using asept inmed brushes.The disinfectant used was anioxyde 1000.The automated endoscope reprocessor (aer) used was not specified.The device was stored horizontally.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The hygiene microbiological investigation report indicated the channels of the scope were cultured and found <(b)(4) colony forming unit (cfu).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 no damage to the device, and it passed all functional testing.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 cystonephrofiberscope tested positive for 1 colony forming unit (cfu) of roseomonas mucosa and for 1 colony forming unit (cfu) of micrococcus.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 the legal manufacturer's final investigation.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 the 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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