Model Number CYF-VHA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930)
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Event Date 05/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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The subject device has not returned to olympus medical systems corp.(omsc) for evaluation yet.There were no further details provided.If significant additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that the user facility found three patients were infected with unspecified microbes on (b)(6) 2020.The three patients underwent endoscopic procedures using cyf-vha on (b)(6) 2020.The patients' outcome is reportedly as follows.First patient: fever.Second patient: fever and hospitalization.Third patient: unknown.The cyf-vha had been reprocessed with an olympus automated endoscope reprocessor model oer-s using peracetic acid.The concentration of disinfectant of the oer-s was effective.The user wipes the cyf-vha with a sterile cloth after automated reprocessing cycle and stores the device in the basin of the oer-s until next procedure.Olympus is submitting 3 medwatch reports for the cyf-vha.This is the 1st of the 3 reports.
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Manufacturer Narrative
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The device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Omsc also reviewed the repair history of the device and confirmed that no abnormalities which contribute to infection were observed in the previous repairs.The customer had stored the endoscope by placing it in the reprocessing basin of the olympus endoscope reprocessing machine, oer-s.The reprocessing basin has high humidity and microorganisms are easy to grow in the environment.Based on the available information above, the endoscope was likely to be contaminated when being stored in the basin.
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Search Alerts/Recalls
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