Model Number URF-P6 |
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 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device in this report has not been returned to olympus medical systems corp.(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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As a result of multiple microbiological testing by the user facility, the following microbes were detected from the sample collected from the device.[first time; (b)(6) 2020] unspecified microbes (6 cfu/100ml) [second time; (b)(6) 2020] unspecified microbes (1 cfu/100ml) [third time; (b)(6) 2020] unspecified microbes (46 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 prodive additional information.The subject device has not been returned to olympus medical system corp.(omsc) but was returned to olympus france.(ofr).Ofr sent the subject device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from all channels of the device.The testing result cleared clear the french guideline.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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