The subject device has not been returned to omsc but was returned to olympus france (ofr).Ofr 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 the instrument channel, suction channel, air/water channel and auxiliary 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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