The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent this device to a third party laboratory for additional microbiological testing.As a result of additional microbiological testing by a third party laboratory, no microbe was detected from samples taken from the instrument channel, suction channel and air/water channel of this device.Therefore, it cleared the french guideline.Also, omsc reviewed the manufacturing history of this device and confirmed no irregularity.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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Olympus medical systems corp.(omsc) was informed that in the routine microbiological test by the user facility, the microbes were detected as follows, from samples taken from the subject device which was reprocessed using a non-olympus automated endoscope reprocessor made by soluscope.The user facility reported that this device was reprocessed according to the instruction manual.There was no report of infection associated with this report.<1st time>: > 100 cfu/100ml: - instrument channel: klebsiella pneumoniae, stenotrophomonas maltophilia, - air/water channel: no microbe.<2nd time>: > 100 cfu/100ml: - instrument channel: klebsiella pneumoniae, pseudomonas aeruginosa, - air/water channel: klebsiella pneumoniae, pseudomonas aeruginosa, stenotrophomonas maltophilia.<3rd time>: > 200 cfu/100ml: - instrument channel: stenotrophomonas maltophilia, pseudomonas aeruginosa, - air/water channel: stenotrophomonas maltophilia , klebsiella pneumoniae.
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