BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XL, 9 ARRAY, 3-5CM, 10CM

    MDR report key: 1215635 · Received October 20, 2008

    Report

    Report Number
    1056436-2007-00084
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    February 21, 2007
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT, "CANNOT MOVE THE SHAFT TO WITHDRAW THE TINES", WAS CONFIRMED. THE SCREW ANCHOR SLIPPED ON THE DRIVE TUBE DUE TO AN INADEQUATE SOLDER AMOUNT BETWEEN THE SCREW ANCHOR AND THE DRIVE TUBE.

    Description of Event or Problem · 1

    CANNOT MOVE THE SHAFT TO WITHDRAW THE TINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XL, 9 ARRAY, 3-5CM, 10CM ELECTROSURGICAL DEVICE GEI ANGIODYNAMICS, INC. NA 26561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other