BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE LCA

    MDR report key: 1823558 · Received August 27, 2010

    Report

    Report Number
    2027111-2010-00090
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 27, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REC'D AND IS CURRENTLY UNDERGOING ENGINEER EVALUATION. A F/U REPORT WILL BE SENT ONCE MORE INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAPAROSCOPIC APPENDIX-PREDICTIVE THEATRE - "SURGEON DEPLOYED THE APPLIER DOWN THE TROCAR. HE TRIED AND LOADED THE FIRST CLIP AND LIGATED THE VESSEL SUCCESSFULLY. HE FIRED APPROX 3 CLIPS SUCCESSFULLY, WITHDREW THE APPLIER. ASKED FOR IT AGAIN AND BEGAN TO FIRE THE APPLIER. ON THIS OCCASION THE APPLIER JAMMED. SURGEON APPLIED FORCE TO FIRE THE CLIP AND THE ONE SIDE OF THE JAWS FELL OFF. A C-ARM WAS REQUESTED AND UNDER C-ARM, YOU COULD CLEARLY SEE THE JAW OF THE APPLIER INSIDE THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE LCA NONE GDO APPLIED MEDICAL RESOURCES CA090 1106843

    Patients

    Seq Age Sex Outcome Treatment
    1