BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERC DLR SPINEWAND SURGICAL DEVICE

    MDR report key: 2434221 · Received January 5, 2012

    Report

    Report Number
    3006524618-2012-00250
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    December 2, 2011
    Report Date
    December 7, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEY
    PMA / PMN Number
    K020621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES, REFERENCE MANUFACTURERS REPORT NUMBERS: 3006524618-2012-00251 AND 3006524618-2012-00252.

    Description of Event or Problem · 1

    DURING SET-UP FOR NUCLEOPLASTY PROCEDURE THE PT WAS SEDATED UNDER GENERAL ANESTHESIA AND A SMALL INCISION WITH 17G CRAWFORD NEEDLE WAS MADE BY INSERTING INTO THE PTS ANATOMY. THE PHYSICIAN INSERTED THE PERC DLR SPINEWAND INTO AN ARTHROCARE CONTROLLER AND TESTED THE WAND (LOT Q115110-A) WITH NORMAL SALINE. THE WAND INDICATOR WAS ILLUMINATED AND DISPLAYED A SET POINT LEVEL OF 2, THE COAGULATION AND ABLATION PETALS WERE DEPRESSED, HOWEVER, THE PHYSICIAN INDICATED THAT NO RF ENERGY WAS GENERATED. A SECOND PERC DLR SPINEWAND FROM THE SAME LOT WAS TESTED AND THE WAND FAILED TO GENERATE RF ENERGY. A THIRD PERC DLR SPINEWAND FROM A DIFFERENT LOT (Q113610-A) WAS ALSO TESTED AND THE WAND FAILED TO GENERATE RF ENERGY. AS A RESULT OF THE EXTENDED WAND TESTING, THE PT WAS UNDER GENERAL ANESTHESIA FOR APPROXIMATELY 1 HOUR AND 30 MINUTES BEFORE THE PROCEDURE WAS ABORTED. THE PT WAS DISCHARGED AND TRANSFERRED TO ANOTHER HOSPITAL SEEKING A SECOND OPINION. IT IS UNK IF THE PT'S SURGERY HAS BEEN RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC DLR SPINEWAND SURGICAL DEVICE ELECTRODES, ELECTROSURGICAL, ACTIVE, FOO GEY ARTHROCARE CORPORATION Q115110-A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention