The 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 channel of the device.The testing result cleared the french 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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Olympus medical systems corp.(omsc) was informed that as a result of microbiological testing by the user facility, following microbes were detected from the sample collected from the device.The air/water channel: staphylococcus capitis (30ufc / endoscope), micrococcus luteus (4 ufc / endoscope).The elevator channel: bacillus cereus (1 ufc / endoscope).The instrument channel: moraxella osloensis (1 ufc / endoscope), kocuria spp (1 ufc / endoscope), staphylococcus capitis (1 ufc / endoscope).The suction channel: staphylococcus capitis (9 ufc / endoscope), micrococcus spp (1 ufc / endoscope).The device had been reprocessed with an olympus automated endoscope reprocessor model etd-4 (not available in the usa) using peracetic acid.There was no report of infection associated with this report.
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