BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERMULTI VAC 50

    MDR report key: 2852657 · Received November 14, 2012

    Report

    Report Number
    3006524618-2012-00877
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE OF THE U.S., DUE TO INTERNATIONAL PRIVACY LAWS, THE PT INFO WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY USING THE SUPERMULTI VC 50 WAND, PARTICLES CAME OFF OF THE ELECTRODE PLATE WHILE INSIDE THE PT. THE PARTICLES WERE RETRIEVED FROM THE PT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERMULTI VAC 50 ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION E913920-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other