BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROCISE EZ PLASMA WAND

    MDR report key: 926109 · Received October 12, 2007

    Report

    Report Number
    2951580-2007-00053
    Event Type
    Other
    Date Received
    October 12, 2007
    Date of Event
    July 1, 2007
    Report Date
    October 5, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K063538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PT INFORMATION IS NOT KNOWN. GENDER NOT KNOWN. (REFERENCE MDRS 2951580-2007-00054, 2951580-2007-00055, 2951580-2007-00056, 2951580-2007-00057). THERE WERE FIVE SEPARATE INCIDENTS INVOLVING 5 DEVICES WHICH OCCURRED BETWEEN JULY AND AUGUST. DATE OF INITIAL PROCEDURE IS AN ESTIMATE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED. THE DEVICE MET ALL SPECIFICATIONS. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    IN 2006, A CLINICAL INCIDENT INVOLVING A PROCISE EZ PLASMA WAND WAS REPORTED TO ARTHROCARE CORPORATION. DURING A TONSILLECTOMY PROCEDURE, THE SCREEN FROM THE TIP OF THE PLASMA WAND WAS REPORTED TO HAVE DETACHED APPROX 30 MINS INTO PROCEDURE AND WAS NOT RETRIEVED. IT IS UNK IF THE FRAGMENT REMAINS IN THE PT. NO INJURY WAS REPORTED AND THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCISE EZ PLASMA WAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA L109470-A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other