Model Number UM-S20-17S |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device and found that the reported phenomenon was duplicated.When it was connected and operated according to the instruction manual, an abnormality was confirmed that the ultrasonic image did not appear.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during the unspecified timing, blood entered the subject device from the ultrasonic transducer of the subject device.The event date was unknown.Other detailed information was not provided.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) confirmed that there was a hole in the distal end of the insertion tube of the subject device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of this event could not be conclusively determined.Omsc surmised that the reported phenomenon occurred since some external force was applied to the distal end of the insertion tube, creating a hole in the distal end of the insertion tube and blood entered through the hole.
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Search Alerts/Recalls
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