Model Number CYF-5 |
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 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.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 microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.[(b)(6) 2019] unspecified microbes (2cfu/100ml).(b)(6)[ 2019].Unspecified microbes (1cfu/100ml) [(b)(6) 2019] unspecified microbes (1cfu/100ml) [(b)(6) 2019] unspecified microbes (7cfu/100ml).[(b)(6) 2019] unspecified microbes (2cfu/100ml).The device had been manually reprocessed using peracetic acid.The user facility did not provide other detailed information such as the reprocessing method.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, following microbes were detected from the sample collected from the all channels of the subject device.[february 14th, 2020] - staphylococcus coagulase negative (5cfu/endoscope) - gram-positive bacteria (2cfu/endoscope) - moisissures (1cfu/endoscope) [february 27th, 2020] - gram-positive bacteria (5cfu/endoscope) the testing result did not clear the french guideline.After the microbiological testing, the evaluation of the subject device by (b)(4) confirmed that there were some scratches in the instrument channel.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 to provide additional information.In the evaluation of olympus (b)(4) the following was confirmed, there was a residue inside the instrument channel port.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 to additional information.The subject device was repaired by olympus (b)(4) and then sent 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 french guideline.Olympus medical systems corp.(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.
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Search Alerts/Recalls
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