Model Number HYF-XP |
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 04/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc for evaluation.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 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 subject device: [first time; (b)(6) 2019]: unspecified microbes (12cfu / 100ml).[second time; (b)(6) 2019]: unspecified microbe (1cfu / 100ml).[third time; (b)(6) 2019]: staphylococcus spp.[fourth time; (b)(6) 2019]: unspecified microbe (1cfu / 100ml).The user facility also informed that the subject device was brand new scope and it had never been used for a patient.The device had been 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).Ofr sent the subject device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from all channels of the device tested positive for bacillus gram (4cfu/endoscope).The testing result cleared the french guideline.The device had been manually reprocessed.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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Search Alerts/Recalls
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