Model Number CYF-VH |
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 02/21/2019 |
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.Omsc reviewed the manufacture history (dhr) of the 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, 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 multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.[first time; (b)(6) 2018] - all channels: gram-positive bacteria (2cfu/endoscope) and staphylococcus coagulase negative (3cfu/endoscope), [second time; (b)(6) 2018] - all channels: gram-positive bacteria (1cfu/endoscope), [third time; (b)(6) 2019] - all channels: staphylococcus coagulase negative (1cfu/endoscope), [forth time; (b)(6) 2018] - all channels: gram-positive bacteria (31cfu/endoscope).The device had been manually reprocessed using peracetic acid.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 all channels of the subject 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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Manufacturer Narrative
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This supplemental report is being submitted as the initial report sent on april 19, 2019 was rejected due to not written in english.The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the 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, this report will be supplemented.
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Search Alerts/Recalls
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