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>: 24 cfu/100ml: - instrument channel: hafnia alvei, citrobacter farmeri, klebsiella pneumoniae.- air/water channel: klebsiella pneumoniae.<2nd time>: 100 cfu/100ml.- all channels: hafnia alvei, citrobacter farmeri, pseudomonas aeruginosa, coagulase - negative staphylococci.<3rd time>: > 100 cfu/100ml.- instrument channel: citrobacter sp.- air/water channel: no microbe.
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This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(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 instrument channel, suction channel and air/water channel of this device.Therefore, it cleared the french guideline.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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