Model Number URF-P5 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Bacterial Infection (1735)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to olympus medical systems corp.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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Event Description
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Olympus was informed that the subject device tested positive for unspecified bacteria during microbiological testing by the facility.The number of the microbes and the position of the subject device, where the microbes were detected, was not reported.There was no report of patient infection associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the additional microbiological testing by the user facility.In the additional test, the testing indicated no microbial growth for the subject 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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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacture history of the device and confirmed no irregularity.
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Manufacturer Narrative
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This supplemental report is submitting to correct "device product code".
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Search Alerts/Recalls
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