Model Number HYF-XP |
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 10/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the all channels of the device.The testing result cleared the french 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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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 device.First time; (b)(6) 2020.Unspecified microbes.Second time; (b)(6) 2020.Unspecified microbes.Third time; (b)(6) 2020.Unspecified microbes.Fourth time; (b)(6) 2020.Unspecified microbes.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 france (ofr).The evaluation by ofr confirmed some physical damages on 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 the re-culturing test result cleared the french guideline.
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Search Alerts/Recalls
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