BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    MDR report key: 2011680 · Received March 1, 2011

    Report

    Report Number
    2951580-2011-00022
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ARTHROWANDS WERE REPORTED AS RETURNING FOR INVESTIGATION. TO DATE THE ARTHROWANDS HAVE NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION AND LOT REVIEW ARE COMPLETED. THE TWO ADD'L ARTHROWANDS USED IN THE SAME PROCEDURE WERE FILED UNDER MDR 2951580-2011-00020, AND 2951580-2011-00021.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING THREE SUPER TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWANDS WAS REPORTED TO ARTHROCARE. DURING AN ARTHROSCOPIC SUBACROMINAL DECOMPRESSION PROCEDURE IN THE PT'S SHOULDER, THE ARTHROWANDS REPORTEDLY WORKED INTERMITTENTLY AND HAD LOW OUTPUT CAUSING THE SETTINGS TO BE INCREASED WHICH REPORTEDLY RESULTED IN APPROXIMATELY 30 MINUTE DELAY IN SURGERY. THERE WAS NO REPORTED ADVERSE EFFECT TO THE PT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER TURBOVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP EZ24000-B

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other