BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBLATOR 30 WITH INTEGRATED CABLE

    MDR report key: 3250256 · Received July 24, 2013

    Report

    Report Number
    3006524618-2013-00308
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 28, 2013
    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 A WRIST ARTHROSCOPY PROCEDURE USING A MICROBLATOR 30 WITH INTEGRATED CABLE WAND, THE DISTAL TIP OF THE WAND ALLEGEDLY BROKE OFF WHILE INSIDE THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED USING A BACK UP WAND. INFORMATION INDICATING WHETHER THE SITE WAS FLUSHED OR X-RAYED WAS NOT PROVIDED. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346599 MICROBLATOR 30 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION A718620-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other