BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA WITH INTEGRATED CABLE

    MDR report key: 3050364 · Received April 8, 2013

    Report

    Report Number
    3006524618-2013-00143
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 7-12 DAYS AFTER A TONSILLECTOMY PROCEDURE USING THE EVAC 70 XTRA WITH THE COBLATOR II SURGERY SYSTEM, THE PT EXPERIENCED A POST OPERATIVE RE-BLEED. NO INFO WAS PROVIDED TO INDICATE THE CONTROLLER SETTINGS AT THE TIME OF USE OR IF THERE WERE COAGULATION ISSUES WITH THE WAND, THEREFORE THE FACILITY IS UNSURE IF THIS ISSUE IS ATTRIBUTED TO THE WAND OR THE CONTROLLER. NO FURTHER INFO WAS PROVIDED CONCERNING THE TREATMENT FOR THE RE-BLEED, HOWEVER NO OTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144397 EVAC 70 XTRA WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 1031496

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other