BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARVAC 90 ICW

    MDR report key: 2802466 · Received October 18, 2012

    Report

    Report Number
    3006524618-2012-00827
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER, AND WEIGHT WERE NOT MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR JUST AFTER THE START OF THE SURGERY A BALL FROM THE PLATE ELECTRODE BECAME LOOSE AND FELL INTO THE JOINT. IT WAS REMOVED AND THE SURGERY WAS COMPLETED USING A SECOND ARTHROWAND WITH NO FURTHER COMPLICATIONS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARVAC 90 ICW ELECTROSURGICAL CUTTING AND COAGULATION DE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention