BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER MULTIVAC 50 WITH INTEGRATED CABLE

    MDR report key: 1029244 · Received April 16, 2008

    Report

    Report Number
    2951580-2008-00025
    Event Type
    Other
    Date Received
    April 16, 2008
    Date of Event
    January 30, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K072865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE DEVICE WILL NOT BE RETURNED TO ARTHOCARE FOR INVESTIGATION BUT WILL BE RETAINED BY THE HOSPITAL. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A COMPLETE INVESTIGATION COULD NOT BE COMPLETED. A REVIEW OF LOT HISTORY RECORD FOR LOT #E931870-A WAS PERFORMED AND THE LOT MET ALL DEVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING AN ARTHOCARE ARTHOWAND WAS REPORTED TO ARTHOCARE CORP. DURING A KNEE ARTHROSCOPY PROCEDURE (SYNOVECTOMY, PARTIAL MENISCECTOMY, CHRONDROPLASTY), IT WAS REPORTED THE SCREEN DETACHED FROM THE TIP OF THE WAND AND REMAINS IN THE PT'S KNEE. THERE IS NO PLAN TO REOPERATE TO REMOVE THE FRAGMENT. THE PT WAS REPORTED TO EXPERIENCE SOME POST-OPERATIVE SWELLING BUT ALL IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER MULTIVAC 50 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA E931870-A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other