BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1121920 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01178
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    July 29, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBTOTAL THYROIDECTOMY PROCEDURE, THE TISSUE PAD WAS SLIDING PROXIMALLY, AND THE SMALL PARTS OF THE PAD FELL INTO THE SITUS. THEY WERE ABLE TO BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 D4JM43

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR