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Model Number HYF-XP |
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 07/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Attempts to retrieve additional information from the customer are in progress.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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Event Description
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The customer reported to olympus, during reprocessing, the oes hysterofiberscope tested positive for 1 colony forming units (cfus) of gram-positive bacteria.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 and the device evaluation.Updated b6: the customer recorded previous culture results in the cds checklist.The culture results were not confirmed because the hmi report was not shared with olympus.The hygiene microbiological investigation results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The hygiene microbiological investigation report indicated the channels of the scope were cultured and 1 colony forming unit of bacillaceae was detected.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The customer did not provide the specific steps taken during the cleaning sterilization and disinfection (cds) process.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed and found the distal end of the insertion part of the biopsy channel was deformed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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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.As a result of confirming the contents of the instruction manual, about reprocess method, it is described on the chapters below: chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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