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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 08/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Prior to device evaluation, the olympus scope was sent to an independent laboratory for culture testing.The hygiene microbiological investigation report indicated all channels of the scope were cultured and tested positive for less than 1 colony forming units (cfus)/ endoscope of microorganism.Overall, the results are in conformance with the requirements.The cleaning sterilization and disinfection (cds) processes has been requested regarding this event.To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
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Event Description
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The customer reported to olympus, during a routine control mandatory request by the french authorities, the uretero-reno videoscope tested positive for 1 colony forming units (cfus) of an unspecified microorganism.All channels were sampled.The user did not report any contamination or any other serious deterioration in the 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 customer completed cleaning sterilization and disinfection (cds) checklist, the device evaluation and the legal manufacturer's final investigation.The customer provided the 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 manual cleaning or automatic cleaning processes.The device was rinsed before manual disinfection.The name of the disinfectant is dng.All channels were flushed and immersed into the disinfectant.Sterile water is used for rinsing after disinfection.The concentration and expiration of the disinfectant is controlled.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 instructions for use (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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