BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA

    MDR report key: 2852652 · Received November 14, 2012

    Report

    Report Number
    3006524618-2012-00875
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    July 16, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES. AS A RESULT OF FOREIGN CONFIDENTIALITY REQUIREMENTS AND INTERNATIONAL PRIVACY LAWS, NO PATIENT INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING THE EVAC 70 XTRA WAND, THE SYSTEM ALERT ON THE CONTROLLER CAME ON. THE SURGEON OPENED UP A NEW WAND AND SWITCHED IT OUT, BUT THE SYSTEM ALERT LIGHT REMAINED ON. THE PROCEDURE WAS EVENTUALLY COMPLETED WITHOUT COBLATION. THERE WERE NO DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAC 70 XTRA ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION B205520-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other