BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA WITH INTEGRATED CABLE

    MDR report key: 2882977 · Received December 18, 2012

    Report

    Report Number
    3006524618-2012-00967
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE UNITES 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 TONSILLECTOMY PROCEDURE USING THE EVAC 70 XTRA, THE WAND EXHIBITED DEFICIENT SALINE FLOW AND THEN SPARKED. THE PROCEDURE WAS COMPLETED USING A BACK UP EVAC 70 XTRA, WITHOUT FURTHER INCIDENT. THERE WERE NO SIGNIFICANT 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 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION B212520-E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other