BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERC DC CONVENIENCE PACK

    MDR report key: 958415 · Received December 5, 2007

    Report

    Report Number
    2951580-2007-00071
    Event Type
    Other
    Date Received
    December 5, 2007
    Date of Event
    October 26, 2007
    Report Date
    November 30, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K010811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED FOLLOWING THE PROCEDURE, THEREFORE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED. THE DEVICE MET ALL SPECIFICATIONS. TWO PERC DC WANDS WERE USED IN THE PROCEDURE AND TWO SEPARATE MDRS ARE FILED FOR EACH DEVICE UNDER MEDWATCH NUMBERS 2951580-2007-00071 AND 2951580-2007-00081.

    Description of Event or Problem · 1

    IN 2007, A CLINICAL INCIDENT INVOLVING A PERC DC WAND WAS REPORTED TO ARTHROCARE. DURING A PLASMA DISC DECOMPRESSION PROCEDURE, THE TIP OF TWO PERC DC WANDS DETACHED AND REMAINED IN THE PT'S CERVICAL DISC AT TWO LEVELS, C5/C6 AND C6/C7. THE PHYSICIAN INDICATED THERE WAS NO PLAN TO REOPERATE TO REMOVE THE FRAGMENT. THERE HAVE BEEN NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC DC CONVENIENCE PACK ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA Q0340860-A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other