The subject device has not been returned to omsc but was returned to olympus (b)(4).Olympus (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 at this time.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.(b)(6) 2018 the subject device tested positive for staphylococcus pasteuri (1cfu / 100ml), micrococcus luteus (1cfu / 100ml) and staphylococcus hemolyticus (1cfu / 100ml).(b)(6) 2018 the subject device tested positive for staphylococcus warneri (countless number).(b)(6) 2018 the subject device tested positive for enterobacter aerogenes (5cfu / 100ml), enterobacter casseliflavus (2cfu / 100ml), staphylococcus hominis (2cfu / 100ml), staphylococus pasteuri (1cfu / 100ml) and kocuria rhizophila (1cfu / 100ml).(b)(6) 2018 the instrument channel of the subject device tested positive for micrococcus luteus (1cfu / 100ml).The suction channel of the subject device tested positive for enterobacter aerogenes (29cfu / 100ml).The device had been reprocessed using peracetic acid.There was no report of infection associated with this report.
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