BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2162420 · Received July 14, 2011

    Report

    Report Number
    3005075853-2011-02885
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RN ADVISED THAT THE BURN IS 1ST DEGREE, NOT 2ND DEGREE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROID PROCEDURE, TOWARDS THE END OF THE CASE THE ALUMINUM NEAR THE HINGE OF THE DEVICE LEFT A SUPERFICIAL BURN MARK ON THE NECK OF THE PATIENT. NO ADDITIONAL TREATMENT WILL BE GIVEN AND THE SURGEON IS CLASSIFYING THE BURN AS A SMALL SECOND DEGREE BURN. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE