Olympus medical systems corp.(omsc) was informed that during routine surveillance culturing test by the facility, the subject device repeatedly tested positive for several microorganism.On (b)(6) 2017, the subject device tested positive for staphylococcus coagulase negative (112cful/170ml)).On (b)(6) 2017, the subject device tested positive for pseudomonas aeruginosa, sphingomonas pauctmobilis,and stenotroohomonus maltophilia (61cfu/190ml in total).On (b)(6), 2017, the subject device tested positive for staphylococcus coagulase negative, comamononas teststosteroni and sphingomonas paucimobilis (4cful/180ml in total).The subject device was brand new and manually reprocessed with peracetic acid.There was no report of infection associated with this report.
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This supplemental report is being submitted to provide the device evaluation result.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the testing indicated no microbial growth for the subject device.
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