Model Number TJF-160VR |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc but was returned to olympus (b)(4).(ofr).Ofr 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 and the distal end of the device.The testing result cleared the (b)(6) guideline.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.Distal end: saprophytic germs (2 cfu) instrument channel: saprophytic germs (1 cfu) auxiliary water channel: acinetobacter (2 cfu) air/water channel: saprophytic germs (3 cfu) suction channel: saprophytic germs (1 cfu) 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.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, it is unlikely that the reported event occurred due to the scope, because the re-culturing test result was negative and there is no report on a damage of the device.
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Search Alerts/Recalls
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