BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVAC XL ARTHROWAND

    MDR report key: 1373616 · Received May 1, 2009

    Report

    Report Number
    2951580-2009-00025
    Event Type
    Other
    Date Received
    May 1, 2009
    Date of Event
    March 27, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE DEVICE HAS BEEN RETURNED AND COMPLETION OF THE INVESTIGATION. THREE DEVICES, MULTIVAC XL ARTHROWANDS, WERE USED IN THE SAME PROCEDURE. THREE SEPARATE MDR REPORTS WILL BE FILED UNDER MDR 2951580-2009-00026, AND MDR 2951580-2009-00027.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING THREE MULTIVAC XL ARTHROWANDS WAS REPORTED TO ARTHROCARE CORPORATION. DURING HIP ARTHROSCOPY PROCEDURE, THE ELECTRODES DETACHED FROM THE TIP OF THE THREE WANDS IN THE SURGICAL SITE. THE ELECTRODES REMAIN IN THE PATIENT'S HIP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVAC XL ARTHROWAND ELECTROSURGICAL CUTTING & COAGULATON DEVICE GEI ARTHROCARE CORP. NA 6122480-1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other