The subject device has not been returned to omsc but was returned to olympus europa (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 the distal end and the instrument channel of the subject device.The testing result cleared the (b)(6) 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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