BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS SYSTEM

    MDR report key: 2833869 · Received November 5, 2012

    Report

    Report Number
    3006524618-2012-00864
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K032504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT IDENTIFIER, AGE, WEIGHT OR GENDER WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE THE CONTROLLER WOULD POWER ON, BUT NOT ACTIVATE THE LOPRO TURBOVAC A1336-01 WAND. THIS RESULTED IN THE PROCEDURE BEING DONE WITH A SHAVER INSTEAD OF AN ARTHROCARE WAND. NO PT COMPLICATIONS OR DELAYS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention