Model Number URF-V |
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 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.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.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 three times microbiological testing by the user facility, the microbes were detected from the sample collected from the subject device.The user facility only provided the following two results: [(b)(6) 2018]: paenibacillus pabuli (10 cfu / ml); [(b)(6) 2018]: unspecified microbes (10 cfu / ml).Other detailed information such as the reprocessing method was not provided.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 (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.The additional microbiological testing indicated no microbial growth for the distal end and instrument channel of the device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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