Model Number CYF-5 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device in this report has not been returned to omsc for evaluation.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, the following microbes were detected from the sample collected from the subject device.[first time; (b)(6) 2020] -all channels: staphylococcus non aureus (9 cfu/endoscope) [second time; (b)(6) 2020] -all channels: filamentous fungi (2 cfu/endoscope) 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 was returned to olympus france (ofr).Ofr sent the device to a third-party laboratory for microbiological testing.As a result of the testing, no microorganism was detected from a sample collected from the all channels of the device.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, it is unlikely that the reported event occurred due to the scope, because no microorganism was detected at the re-culturing test.
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Search Alerts/Recalls
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