BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA WITH INTEGRATED CABLE

    MDR report key: 4202594 · Received September 18, 2014

    Report

    Report Number
    3006524618-2014-00293
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    May 25, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING AN EVAC 70 XTRA ICW WAND, THE WAND WOULD NOT ACTIVATE. AFTER A DELAY OF 30 MINUTES TO DETERMINE THE ISSUE, THE WAND WAS REPLACED WITH A BACKUP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580762 EVAC 70 XTRA WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORP 1063433

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other