BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 2000636 · Received February 24, 2011

    Report

    Report Number
    3005075853-2011-00739
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    April 29, 2010
    Report Date
    January 18, 2011
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE BLADE WAS NOT PROPERLY ALIGNED TO THE TISSUE PAD. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL, HOWEVER, CHIRPING NOISE WAS HEARD COMING FROM THE INSTRUMENT. THE INSTRUMENT WAS DISASSEMBLED AND IT WAS FOUND TO HAVE THERMAL DAMAGE AT THE SHROUDS AND INSULATED PIN INTERFACE. THIS DAMAGE COULD HAVE RESULTED FROM NOT TORQUING THE INSTRUMENT PROPERLY TO THE HAND PIECE; RESULTING IN EXCESSIVE HEAT GENERATION AND NOISE TO BE HEARD.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE PRODUCT PRESENTED NOISE AND HEAT. THE BLADE TIP WAS HOT. UNKNOWN HOW CASE WAS COMPLETED. 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 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK F4PW4J

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE