Model Number URF-P7 |
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 07/17/2023 |
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 hygiene microbiological investigation report indicated the channels of the scope were cultured and found < 1 cfu/100ml.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 defects with the device.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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The customer reported to olympus, during reprocessing, the uterero-reno fiberscope tested positive for 7/100ml colony forming units (cfus) of micro-organisms.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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Event Description
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Correction to b5 of the initial report.The user provided the following result of culture test, performed by the third-party labs: sampling date: (b)(6) 2023.Sampling from: all channels.Cfu: 4cfu/100ml.Bacterial identification: n/a.Sampling date: (b)(6) 2023.Sampling from: all channels.Cfu: 14cfu/100ml.Bacterial identification: n/a.Sampling date: (b)(6) 2023.Sampling from: all channels.Cfu: 7ufc.Bacterial identification: n/a.
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Search Alerts/Recalls
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