Model Number URF-V2 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/28/2021 |
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 but was returned to (b)(4).The evaluation is in progress currently.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 routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.-instrument channel: coagulase-negative staphylococci (3 cfu/endoscope) 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.As a result of the testing, no microbe was detected from the sample collected from the all channels of the subject device.The testing result cleared the (b)(6) guideline.(b)(4) checked the subject device and there was no abnormality of the subject device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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