BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2150662 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02773
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE DEVICE DID NOT COAGULATE PROPERLY; NOT ACTIVATING PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD TO BE BROUGHT BACK TO OR POST OPERATIVELY FOR BLEEDING. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK H43D65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE