BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVAC 50 XL ICW

    MDR report key: 2170112 · Received June 21, 2011

    Report

    Report Number
    2951580-2011-00077
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ARTHROCARE FOR INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICE LOT MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT A HIP ARTHROSCOPY PROCEDURE, USING A MULTIVAC 50 XL ICW ARTHROCARE WAND. ALLEGEDLY, ONE ELECTRODE FROM THE DISTAL TIP OF THE WAND BEGAN TO PEEL AWAY AND ONE OF THE ELECTRODES CAME OFF IN THE PT'S HIP. A C-ARM WAS USED AND IT WAS NOTED THAT THE ELECTRODE WAS EXTRA-CAPSULAR. THE ELECTRODE BALL WAS LEFT IN THE SURGICAL SITE, AND THE SURGEON HAS NO PLAN TO RE-OPERATE TO REMOVE THE DETACHED ELECTRODE. NO PT INJURY OR ADVERSE EFFECT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVAC 50 XL ICW ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. EF08510-A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other