BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1822673 · Received November 27, 2007

    Report

    Report Number
    3005075853-2007-00005
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Report Date
    November 21, 2007
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL THYROIDECTOMY PROCEDURE, THE SURGEON WAS EXPERIENCING ISSUES WITH HEMOSTASIS. THE SURGEON HAD TO USE BOVI TO SEAL ABOUT A THIRD TO A HALF OF THE VESSEL. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST NONE LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE