Model Number UM-G20-29R |
Device Problems
Fluid/Blood Leak (1250); 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 Date 10/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device and the subject sterilization pack were returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device by visual examination and there was no abnormality in the appearance of the subject device.The foreign material like oil stains had adhered to the subject sterilization pack.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 after ethylene oxide gas sterilization, it was found that the foreign material like oil stains adheres to the sterilization pack (hogy hybrid bag hm-1307 (other company's product)).The user has been sterilized three times, but the foreign material like oil stains adheres to the sterilization pack.Since this phenomenon has occurred, the user is not using the subject device.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.Olympus medical systems corp.(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 leaking the ultrasonic propagation fluid medium.
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Search Alerts/Recalls
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