BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIB

    MDR report key: 1701148 · Received May 14, 2010

    Report

    Report Number
    1056436-2010-00029
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 13, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIME BUSTED OFF IN PATIENT DURING CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other