BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST TALON SEMI-FLEX

    MDR report key: 1215633 · Received October 20, 2008

    Report

    Report Number
    1056436-2008-00053
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    June 12, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED, DUE TO THE DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    THE TALON TINES WOULD NOT FULLY RETRACT. THEY STICK OUT SLIGHTLY, WHICH WOULD NOT ALLOW THE DEVICE TO BE INSERTED INTO THE PATIENT. THE DOCTOR TRIED TO USE IT, BUT IT KEPT GETTING HUNG UP ON THE INSIDE OF THE PATIENT'S CHEST WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST TALON SEMI-FLEX ELECTROSURGICAL PROBE GEI ANGIODYNAMICS, INC. NA 957342

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other