BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENIVAC WITH INTEGRATED CABLE

    MDR report key: 1001460 · Received February 21, 2008

    Report

    Report Number
    2951580-2008-00006
    Event Type
    Other
    Date Received
    February 21, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTING OF THE DEVICE WAS PERFORMED. THE VISUAL EXAMINATION CONFIRMED THE DEVICE WAS RETURNED WITH BENT AND BROKEN ELECTRODE WIRES. THE DETACHMENT OF THE ELECTRODE WAS DUE EXCESSIVE ELECTRODE WEAR AND MECHANICAL FAILURE. ARTHROCARE HAS INCLUDED IN THE INSTRUCTIONS FOR USE FOR THE DEVICE THE FOLLOWING WARING: "EXCESSIVE WEAR OF ELECTRODES MAY RESULT FROM VIGOROUS USE AGAINST BONY SURFACES."

    Description of Event or Problem · 1

    ON JANUARY 15, 2008, A CLINICAL INCIDENT INVOLVING A MENIVAC WITH INTEGRATED CABLE WAS REPORTED TO ARTHROCARE CORPORATION. DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE ELECTRODE WAS MISSING FROM THE TIP OF THE WAND AND MAY STILL REMAIN IN THE PATIENT'S KNEE. THERE IS NO REPORTED INJURY TO THE PATIENT AND NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENIVAC WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other