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, the following results were obtained.Therefore, it cleared the french guideline.Total channel: 3 cfu/100ml (ochrobactrum anthropic, micrococcaceae, coagulase - negative staphylococci).Instrument channel: 5 cfu/100ml (ochrobactrum anthropi).Suction channel: 3 cfu/100ml (micrococcaceae).Air/water channel : no microbe.Auxiliary water channel: 5 cfu/100ml (coagulase - negative staphylococci).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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