Model Number CYF-5 |
Device Problems
Break (1069); Microbial Contamination of Device (2303)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device 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 multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the device.[first time; (b)(6) 2020] instrument channel: unspecified microbes (7 cfu) [second time; (b)(6) 2020] instrument channel: unspecified microbes (11 cfu) 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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The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus france.(ofr).Ofr sent the subject 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 device.The testing result cleared clear the french guideline.Ofr checked the subject device and found following.The winding part of the a rubber was peeled off.There was a scratch inside the biopsy channel.The biopsy port was deformed.This defect cause may be physical stress during handling at the user facility or stress during removal of forceps parts performed during inspection at olympus.Omsc reviewed the manufacturing history (dhr) of the subject 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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