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 has not been returned to omsc.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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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, the sample collected from the subject device tested positive for unspecified microbe.The device had been reprocessed using peracetic acid.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 and the subject device evaluation result.The detailed results of the microbiological testing by the user facility were as follows.(b)(6) 2018: the subject device tested positive for neisseria flava (5cfu/ml).(b)(6) 2018: the subject device tested positive for micrococcus luteus (1cfu/ml).(b)(6) 2018: the subject device tested positive for micrococcus luteus (1cfu/ml).The facility had been manually reprocessed the device.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.It was confirmed that the device was manufactured on april 27th, 2015.The subject device has not been returned to olympus medical systems corp.(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 all channels of the subject device.The testing result cleared the (b)(4) 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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Search Alerts/Recalls
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