BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CLIP APPLIER DIRECT DRIVE 10MM

    MDR report key: 1172646 · Received September 10, 2008

    Report

    Report Number
    2027111-2008-00047
    Event Type
    Other
    Date Received
    September 10, 2008
    Date of Event
    July 23, 2008
    Report Date
    September 5, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT PRODUCT HAS JUST BEEN RECEIVED. WE WILL PROVIDE FOLLOW UP UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    "INITIALLY NO CLIPS ADMINISTERING. THEN CLIPS NOT PROPERLY CLIPPING OVER VESSEL - NOT DEPLOYING CORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CLIP APPLIER DIRECT DRIVE 10MM NONE GDO APPLIED MEDICAL RESOURCES CA080 1052915

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization