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 all channels of the subject device.The testing result cleared the (b)(6) guideline.Omsc reviewed the manufacture history of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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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 subject device.On (b)(6) 2018, the instrument channel of the subject device tested positive for unspecified microbes (17cfu/100ml).On (b)(6) 2018, the instrument channel of the subject device tested positive for unspecified microbes (>100cfu/100ml).The facility had been manually reprocessed the device using peracetic acid.There was no report of infection associated with this report.
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