Model Number URF-P7 |
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 Date 09/16/2020 |
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.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 routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Unspecified microbes (+1 cfu/100ml).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.No deviation in the reprocessing procedure at the site from the ifu was detected.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 additional microbiological testing by the third-party laboratory, no microorganisms were detected from the sample taken from all the channels of the device.The evaluation of the device by (b)(4) confirmed that no device problem found.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 phenomenon is due to scope, because there was no report on abnormality of the scope and the re-culturing test result was negative.
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Search Alerts/Recalls
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