BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1160673 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01528
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Report Date
    August 14, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PAD WAS SLIPPING ON THE DEVICE JAWS DURING USE ON THE PATIENT. THE BLADE TIP WAS GETTING HOT AND LEFT SOME SMALL MARKS ON THE PATIENT. THERE WAS NO BURN LEVEL REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT IS STABLE.

    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 E9F287

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR