Model Number UHI-4 |
Device Problems
Contamination /Decontamination Problem (2895); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Olympus medical systems corp.(omsc) was informed by the customer that the exhaust valve did not close.There was no report of patient injury associated with the event.The event date was unknown.
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Manufacturer Narrative
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The subject device was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found that the reported phenomenon could not be duplicated.It was also found that black liquid was in the pipeline due to insufficient reprocessing.The exact cause of the reported event could not be conclusively determined at this time.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 manufacturing record was reviewed and found no irregularities.Omsc re-evaluated the reported event that the exhaust valve did not close, and judged that it was not reportable.According to the inspection result by sorc, black liquid was in the pipeline, but no other abnormalities were found.The exact cause of black liquid in the pipeline could not be conclusively determined.
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Event Description
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This report was submitted for black liquid in the pipeline due to insufficient reprocessing found during device evaluation.
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Search Alerts/Recalls
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