Model Number CYF-5 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.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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Event Description
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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]: all channels: micrococcaceae (18 cfu / endoscope).[second time; (b)(6) 2018]: all channels: staphylococcus coagulase negative (1 cfu / endoscope).[third time; (b)(6) 2018]: all channels: micrococcaceae (2 cfu / endoscope).[fourth time; (b)(6) 2018]: all channels: pseudomonas alcaligenes (7 cfu / endoscope).The testing result does not clear the (b)(6) guideline.The device had been manually reprocessed using peracetic acid.There was no report of infection associated with this report.
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Manufacturer Narrative
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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 an additional microbiological testing.As a result of the testing, no microbe was detected from the sample collected from all the channels of the subject device.The testing result cleared the (b)(4) guideline.The exact cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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