BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRISTAR 50 WITH INTEGRATED CABLE

    MDR report key: 3213978 · Received July 3, 2013

    Report

    Report Number
    3006524618-2013-00279
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    December 1, 2012
    Report Date
    June 10, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP APPOINTMENT 7 MONTHS POST ARTHROSCOPIC KNEE SURGERY USING A TRISTAR 50 WAND, THE DOCTOR DISCOVERED THERE WAS A FOREIGN OBJECT IN THE KNEE. THE DOCTOR WAS PERFORMING AN X-RAY FOR A POST-OPERATIVE CHECK, WHEN THE FOREIGN OBJECT WAS DETECTED. THE DOCTOR ALLEGES THAT IT MIGHT BE A PIECE OF THE SCREEN FROM THE TRISTAR 50 WAND, HOWEVER THE ORIGIN OF THE OBJECT IS UNCONFIRMED AT THIS TIME. THE PT HAS NOT HAD ANY PAIN OR IRRITATION IN THE KNEE SINCE THE PROCEDURE, SO THE DOCTOR HAS NOT REMOVED THE PIECE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303595 TRISTAR 50 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other