BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1190750 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02157
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Report Date
    September 15, 2008
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. THE TISSUE PAD WAS EXAMINED AND NORMAL WEAR WAS VISUALLY SEEN. FLAKING OF THE TISSUE PAD MAY BE CAUSED DUE TO ACTIVATION OF THE DEVICE WHILE CLAMPING WITHOUT TISSUE BEING PRESENT IN THE ENTIRE JAW AREA. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN DAMAGE TO THE INSTRUMENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE DEVICES TISSUE PAD WAS MELTING WHILE TISSUE WAS IN THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST LFL ETHICON ENDO-SURGERY, LLC NA E4KN83

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR