Model Number URF-V2 |
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 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 microbiological testing by the user facility, unspecified microbes were detected from the sample collected from the subject device.
The device had been manually reprocessed.
The user facility did not provide other detailed information such as the number of microbes and the type of microbes.
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.
Olympus medical systems corp.
(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from all channels of the subject device tested positive for staphylococcus warneri (28cfu).
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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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.
The subject device has not been returned to omsc but was returned to (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 (b)(6) 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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