BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST TALON SEMI-FLEX

    MDR report key: 1215645 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00078
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    May 12, 2006
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. FROM THE INVESTIGATION, IT APPEARS THAT THE DEVICE WAS REINSERTED WHILE STILL PARTIALLY DEPLOYED. THIS CAUSED THE TINES TO BEND TOWARD THE HANDLE, CREASING AND CREATING A WEAK POINT ON THE TINES. THE TINES SHEARED OFF AT THE WEAK POINT AS THEY WERE BEING RETRACTED. IT IS NECESSARY TO FULLY RETRACT THE DEVICE BEFORE REPOSITIONING. THIS EVENT APPEARS TO BE RELATED TO USER ERROR.

    Description of Event or Problem · 1

    TALON PERFORMED FIRST BURN AS INTENDED. THE RADIOLOGIST EXPERIENCED DIFFICULTY BRINGING THE TINES BACK IN. WHEN HE FINALLY GOT THEM BACK IN AND REMOVED THE DEVICE FOR REDEPLOYMENT TO ANOTHER LESION, THE DISTAL 3 OR 4 MM OF EACH TINE SHEARED OFF AND REMAINED IN THE PT. THEY COULD SEE THE PARTICLES OF THE SHEARED TINES IN THE LIVER UNDER CT GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST TALON SEMI-FLEX ELECTROSURGICAL PROBE GEI ANGIODYNAMICS, INC. NA 26565

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other