The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for microbiological testing and the testing indicated no microorganisms growth for the subject device.The exact cause could not be determined at present, if significant additional information is received, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed that during a routine surveillance culturing conducted by the user facility, the subject device tested (b)(6) for unspecified microorganism.The facility also informed that the subject device was re-tested twice, and the subject device tested (b)(6) for the following some kinds of bacteria.First time: (b)(6) (total of microbial colony count 5 cfu/ endoscope).Second time: (b)(6) (1cfu/endoscope).There was no report of infection associated with this report.
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