Model Number CYF-5 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.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 multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.[first time; the date is unknown] : unspecified microbes (>79cfu / 100ml) [second time; (b)(6) 2018] : no microbe.The facility had been manually reprocessed the device.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 the additional information.(b)(4) reviewed the manufacturing history of the subject device and confirmed no irregularity.It was confirmed that the device was manufactured on february 23th, 2012.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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