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 07/30/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that the subject device tested positive for nisseria subflava and streptococcus sp.(59cfu/endoscope in total) during a routine surveillance culturing test at the facility.It was reported that the user facility had manually reprocessed the subject device with peracetic acid.There was no report of patient infection associated with the event.
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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.But was returned to olympus (b)(4).The subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the test result indicated no microbial growth for the subject device.The exact cause could not be determined.
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Search Alerts/Recalls
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