BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC SPINEWAND W/ CIQ

    MDR report key: 2975561 · Received February 7, 2013

    Report

    Report Number
    3006524618-2013-00065
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CERVICAL NUCLEOPLASTY PROCEDURE USING THE DC SPINEWAND W/ CIQ, THE WAND DISPLAYED AN ERROR. THE PROCEDURE WAS STOPPED AND POSTPONED BECAUSE THERE WAS NOT A BACKUP DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53254 DC SPINEWAND W/ CIQ ELECTORDE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other