Model Number OER-AW |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2021 |
Event Type
malfunction
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Event Description
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Olympus medical systems corp.(omsc) was informed that there was water sample problem and positive culture results for rinse water of oer-aw.There was no report of patient infection associated with the event.In addition, omsc received the following information.- the user replaced all filters of oer-aw, and performed dis line after testing lcg with test strip.- after that drain lcg, connected to sampling tube and performed program 2 reprocessing.- finally function selected rinse to get the sampling.- but the result still found mold.
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Manufacturer Narrative
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The subject device was returned to local service department of olympus.The exact cause has been under investigation.If additional information is received, this report will be supplemented.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Omsc presumed the following possible causes.Continued to use the water filter for longer than the period recommended by olympus.Disinfection of water supply tube was not carried out.The disinfectant was deteriorated.Contamination during sampling.
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Search Alerts/Recalls
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