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 Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the all channels of the device.The testing result cleared the (b)(6) guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Filamentous fungus (1 cfu/endoscope).Other detailed information such as the reprocessing method was not provided.The occurrence date of the event was (b)(6) 2021.There was no report of infection associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The device had been manually reprocessed using peracetic acid.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was returned to olympus france.(ofr).Nonconformity of the subject device, which may affect the reported event, was not confirmed via device inspection result of ofr.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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