BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER TURBOVAC 90 ICW

    MDR report key: 4180277 · Received October 15, 2014

    Report

    Report Number
    3006524618-2014-00302
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE USING A SUPER TURBOVAC 90 ICW WAND, THE TIP OF THE WAND DETACHED WHILE INSIDE THE SURGICAL SITE. THE SITE WAS FLUSHED AND X-RAYED TO ENSURE THAT NO DEBRIS WAS LEFT IN THE SITE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER DELAY USING A BACKUP WAND. 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
    652959 SUPER TURBOVAC 90 ICW ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION 1071290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other