BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1667546 · Received April 22, 2010

    Report

    Report Number
    2027111-2010-00055
    Event Type
    Other
    Date Received
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANTICIPATED TO RETURN, F/U WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    "CLIP DID NOT CLOSE. DISLOCATION OF THE CLIP APPLIER CAUSING THE CUT OF THE CYSTIC ARTERIAL AND HEMORRHAGES. CUSTOMER REPORTS THIS IS THE SECOND TIME THIS HAPPENS." "SURGEON CHANGED CLIP APPLIER AND HAD TO PERFORM HEMOSTASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CA090 1106266

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention