BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1080011 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00537
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 23, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PARATHYROID/THYROID CASE, THE DOCTOR EXPERIENCED HEAT NEAR HIS FINGERS, SPECIFICALLY THE MAX SWITCH BUTTON. THE DISCOMFORT WAS ENOUGH TO HAVE THE DOCTOR SWITCH TO A NEW DEVICE. THE CASE WAS COMPLETED WITH THE SECOND INSTRUMENT. NO CONSEQUENCE OCCURRED 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR