BEUDAMED
    FDA Adverse Event Other Summary report: N

    11 GAUGE CAVITY SPINEWAND

    MDR report key: 988837 · Received January 29, 2008

    Report

    Report Number
    2951580-2007-00097
    Event Type
    Other
    Date Received
    January 29, 2008
    Date of Event
    December 19, 2007
    Report Date
    January 18, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K063172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED BY THE USER FACILITY FOR INVESTIGATION. THE USER FACILITY REPORTED THERE WERE NO PROBLEMS ASSOCIATED WITH THE USE DEVICE FOR THIS REPORT. THERE ARE NO OTHER SIMILAR REPORTS FOR THIS DEVICE. TWO DEVICES, 11 GAUGE CAVITY SPINEWAND (CATALOG NO. KP-CAV-7700-01) AND 11 GAUGE, T-GRIP ACCESS NEEDLES (CATALOG NO. KP-TGN-11), WERE USED IN THE SAME PROCEDURE AND TWO SEPARATE MDRS ARE FILED FOR EACH DEVICE UNDER MEDWATCH NUMBERS 2951580-2007-00097 AND 2951580-2007-00098.

    Description of Event or Problem · 1

    IN 2007, A CLINICAL INCIDENT INVOLVING A ARTHROCARE CAVITY WAND AND AN ARTHROCARE T-GRIP NEEDLE WAS REPORTED TO ARTHROCARE. FOLLOWING A VERTEBROPLASTY WITH COBLATION PROCEDURE, THE PT WAS REPORTED AS COMPLETELY PARALYZED BELOW WAIST. IT WAS REPORTED THAT THE ARTHROCARE CAVITY WAND AND ARTHROCARE T-GRIP NEEDLE HAD FUNCTIONED PROPERLY DURING THE SURGERY AND THERE WERE NO REPORTED PROBLEMS DURING THE PROCEDURE. IN 2008, THE PHYSICIAN WAS CONTACTED FOR PT STATUS. THE PT'S CONDITION OF PARALYSIS HAS NOT CHANGED AND THE PT WILL REQUIRE REHABILITATION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11 GAUGE CAVITY SPINEWAND ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability