BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAVAC WITH INTEGRATED CABLE

    MDR report key: 1006490 · Received March 5, 2008

    Report

    Report Number
    2951580-2008-00017
    Event Type
    Other
    Date Received
    March 5, 2008
    Date of Event
    December 24, 2007
    Report Date
    February 29, 2008
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K070958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. AWAITING FURTHER DETAILS REGARDING THIS EVENT. TWO DEVICES, ULTRAVAC WITH INTEGRATED CABLE (CATALOG NO ASC5000-01) AND ATLAS CONTROLLER (CATALOG NO H3000-00), WERE USED IN THE SAME PROCEDURE AND TWO SEPARATE MDRS ARE FILED FOR EACH DEVICE UNDER MEDWATCH NUMBERS 2951580-2008-00017 AND 2951580-2007-00018.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING AN ULTRAVAC ARTHROWAND AND ATLAS CONTROLLER WAS REPORTED TO ARTHROCARE CORPORATION. DURING AN ARTHROSCOPY PROCEDURE OF THE KNEE, THE PATIENT SUSTAINED A BURN (SEVERITY, LOCATION, AND SIZE NOT DISCLOSED). AWAITING FURTHER INFORMATION REGARDING INJURY, TREATMENT, AND PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVAC WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORPORATION NA 5E24370-A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other