BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIMINATOR ICW

    MDR report key: 2850165 · Received November 21, 2012

    Report

    Report Number
    3006524618-2012-00911
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE USING AN ELIMINATOR 90 ARTHROWAND, THE TIP OF THE WAND BROKE OFF AND FELL INTO THE JOINT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY AND THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELIMINATOR ICW ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION 4V29410-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention