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Model Number URF-V3 |
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 been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The legal manufacture reviewed the customer provided the cleaning disinfection and sterilization (cds) processes where the results are still pending.The hygiene microbiological investigation report indicated the channels of the scope were cultured and less then one colony forming unit of revivable micro-organisms.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 other issues.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 six colony forming units (cfus) of a revivable aerobic flora.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 device evaluation and the legal manufacture's final investigation.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.The device was evaluated where 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 the ifu before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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