BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCISE XP PLASMAWAND

    MDR report key: 2222551 · Received August 11, 2011

    Report

    Report Number
    2951580-2011-00113
    Event Type
    Other
    Date Received
    August 11, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING FURTHER INFO IF THE DEVICE WILL BE RETURNED FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED WITH THE LOT HISTORY RECORD REVIEW IF THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY AND ADENOIDECTOMY USING A PROCISE XP PLASMAWAND, THE WAND SUDDENLY BECAME NONFUNCTIONAL AFTER APPROX 15 MINUTES OF USE. WHEN THE WAND WAS EXTRACTED FROM THE PT, THE PHYSICIAN REPORTEDLY NOTED THAT TWO OF THE THREE ELECTRODES WERE MISSING FROM THE DISTAL END OF THE WAND AND THE THIRD ELECTRODE APPEARED TO BE FRACTURED. THE PHYSICIAN WAS FORCED TO TEMPORARILY DISCONTINUE THE PROCEDURE IN ORDER TO INTRODUCE A NEW PLASMAWAND INTO THE SURGICAL FIELD. DURING THIS TIME, THE PHYSICIAN HAD NO MEANS OF CONTROLLING THE PT'S BLEEDING AT THE SURGICAL SITE. IN ORDER TO LOCATE AND RETRIEVE THE DEVICE FRAGMENTS, THE PT UNDERWENT AN X-RAY OF THE SURGICAL SITE; HOWEVER, NO FRAGMENTS WERE SEEN ON THE X-RAY. THE TOTAL REPORTED DELAY TO THE SURGICAL PROCEDURE WAS 45 MINUTES. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCISE XP PLASMAWAND ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. 3607310-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention