BEUDAMED
    FDA Adverse Event Other Summary report: N

    TALON ELECTROSURGICAL DEVICE, 15CM

    MDR report key: 1629952 · Received March 11, 2010

    Report

    Report Number
    1056436-2010-00012
    Event Type
    Other
    Date Received
    March 11, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 10, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR PLACED THE NEEDLE INTO THE TUMOR (LIVER), DEPLOY THE HOOKS, CONTROL THE PLACEMENT WITH ULTRASOUND = OK. PUSH THE "RF" BUTTON TO START THE GENERATOR AND THE GENERATOR SHOW ON THE DISPLAY "BAD DEVICE". REVERSE THE NEEDLE AND SEE THAT ONE OF THE HOOKS ARE BREAK OUT. MUST RECOVER THE "LOST" HOOK WITH GRASP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALON ELECTROSURGICAL DEVICE, 15CM RFA PROBE GEI ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other