BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBLATER 30 WITH INTEGRATED CABLE

    MDR report key: 3030976 · Received March 28, 2013

    Report

    Report Number
    3006524618-2013-00131
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYNOVECTOMY PROCEDURE USING THE MICROBLATER 30 WITH INTEGRATED CABLE, THE TIP OF THE WAND BROKE OFF WHILE INSIDE THE WRIST JOINT. THE PROCEDURE HAD TO BE CONVERTED TO A MINI OPEN, BUT AFTER 2 1/2 HRS THE SURGEON WAS STILL UNABLE TO RETRIEVE THE BROKEN TIP. THE BROKEN PIECE WILL REMAIN IN THE PT UNTIL SUCH TIME IT MAY PRESENT ISSUES OR PAIN FOR THE PT. THE PT WAS TREATED WITH ANTIBIOTICS POST OPERATIVELY AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129521 MICROBLATER 30 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other