Model Number GIF-H190 |
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 06/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not yet been returned to omsc for evaluation.Omsc reviewed the manufacture history 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 or if the device is returned at a later time, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during a surveillance culturing at the user facility the subject device tested positive for staphylococcus non aureus (43 cfu).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 the device evaluation result.(b)(4) sent the subject device to a third party laboratory for additional microbiological testing.In the test, the biopsy channel of the subject device tested positive for staphylococcus coagulase -negative (2 cfu /endoscope).The result of the additional microbiological testing by a third party laboratory satisfied the french guideline.
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Manufacturer Narrative
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This supplemental report is submitting to correct "device product code" and "pma/510(k) number".
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Search Alerts/Recalls
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