BEUDAMED
    FDA Adverse Event Summary report: N

    SUPER MULTIVAC 50

    MDR report key: 1010518 · Received February 11, 2008

    Report

    Report Number
    1010518
    Date Received
    February 11, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 11, 2008
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE ARTHROCARE RADIOFREQUENCY UNIT DURING AN ELBOW PROCEDURE. WHILE THE HANDPIECE WAS ACTIVATED, THE TIP FELL OFF. THE SURGEON IMMEDIATELY RETRIEVED IT FROM THE ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER MULTIVAC 50 HANDPIECE, RF GEI ARTHROCARE CORPORATION UNK E931870-A

    Patients

    Seq Age Sex Outcome Treatment
    1 *