BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEWINDER BLADE ICW

    MDR report key: 2850175 · Received November 21, 2012

    Report

    Report Number
    3006524618-2012-00917
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    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 DURING A HIP ARTHROSCOPY PROCEDURE USING SIDEWINDER BLADE ICW WAND, THE WAND PRESENTED AN ERROR MESSAGE AND THE SCREEN SHOWED INTERFERENCE WITH THE CAMERA. THE WAND WAS ALSO REPORTEDLY SHORTING OUT. ANOTHER SIDEWINDER WAND WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDEWINDER BLADE ICW ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION 6934110-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other