BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER MULTIVAC 50 WITH INTEGRATED CABLE

    MDR report key: 2944013 · Received January 31, 2013

    Report

    Report Number
    3006524618-2013-00051
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MEDIAL MENISECTOMY PROCEDURE USING THE SUPER MULTIVAC 50 ICW, THE WAND APPEARED TO STOP FUNCTIONING PROPERLY. THE SURGEON REMOVED THE WAND FROM THE SURGICAL SITE, THEN NOTED THAT THE TIP OF THE WAND APPEARED TO BE MISSING. THE PT WAS GIVEN AN X-RAY, WHICH SHOWED 3 SMALL FRAGMENTS REMAINED INSIDE THE PT'S KNEE JOINT. THIS EVENT RESULTED IN A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO FURTHER PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42546 SUPER MULTIVAC 50 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1