BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 3113435 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02334
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE DEVICE WAS RETURNED WITH THE TISSUE PAD MELTED AND PARTIALLY DETACHED. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GENERATOR AND THE DEVICE DID ACTIVATE DURING FUNCTIONAL TESTING. PROBABLE CAUSES OF TISSUE PAD DAMAGE ARE APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THE BLADE AND TISSUE PAD; AND ACTIVATING THE BLADE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. BOTH CONDITIONS CAN RESULT IN PROBABLE DAMAGE TO THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PAROTIDECTOMY OF A TUMOR PROCEDURE, PART OF THE WHITE COATING, THE NON-ACTIVE PART CAME OFF AND FELL INTO THE PATIENT. THE PIECE WAS REMOVED WITH FORCEPS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214179 HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J4CH39

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE