BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1910117 · Received February 5, 2008

    Report

    Report Number
    3005075853-2008-00014
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A THYROID PROCEDURE, THE DEVICE WAS CHIRPING MORE THAN NORMAL AND CUTTING VERY SLOW. THEY USED ANOTHER LIKE DEVICE TO COMPLETE CASE WITH NO PT CONSEQUENCES.

    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 D4JK2X

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR