Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device: [first time; (b)(6) 2018] unspecified microbes (2cfu / 100ml), [second time; (b)(6) 2018] unspecified microbes (2cfu / 100ml).The device had been manually reprocessed using peracetic acid.There was no report of infection associated with this report.
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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 the subject device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from all channels of the subject device tested positive for gram-positive bacteria (1cfu/endoscope).The testing result cleared the (b)(4) 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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