BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBL

    MDR report key: 1878695 · Received October 5, 2010

    Report

    Report Number
    1056436-2010-00072
    Event Type
    Other
    Date Received
    October 5, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE WAS DEPLOYED IN PLACE AND THE TUMOR ABLATION WAS PERFORMED. THEN THE PRONGS WERE PULLED INTO THE NEEDLE (UNDEPLOYED), REPOSITIONED INTO A DIFFERENT SEGMENT OF THE TUMOR AND DEPLOYED AGAIN. WHEN THE NEEDLED PRONGS WERE PULLED INTO THE SHAFT AGAIN (UNDEPLOYED), THE CONTROL PANEL OF THE MACHINE GAVE AN ERROR MESSAGE AND WHEN THE NEEDLE WAS REMOVED, A SMALL PIECE OF ONE THE NEEDLE PRONGS WAS MISSING. CT SHOWED THE SMALL PIECE SITTING IN THE PLEURAL SPACE ADJACENT TO THE TUMOR. THE PIECE APPEARS TO HAVE BROKEN OFF DURING THE SECOND UNDEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBL RFA PROBE GEI ANGIODYNAMICS NA 508772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other