BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    MDR report key: 1081610 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00669
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K063192
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL THYROIDECTOMY PROCEDURE, THE CLAMP FORCE OF THE JAWS WAS NOT TIGHT AND FIRM, RESULTING IN IMPROPER SEALING OF VESSELS. WHEN THE SURGEON WAS SEALING THE INFERIOR THYROID VESSELS, AFTER THE INSTRUMENT COAGULATED AND CUT THROUGH THE VESSEL, THE MIDDLE OF THE VESSEL SNAPPED OPEN, RESULTING IN BLEEDING THAT REQUIRED THE SURGEON TO CLAMP AND TIE THE VESSEL USING A LIGATURE. THE SURGEON CONTINUED TO USE THE INSTRUMENT TO SEAL OTHER SMALL VESSELS AND THE SAME ISSUE HAPPENED A COUPLE OF TIMES. ONCE THE SPECIMEN WAS OUT AND HEMOSTASIS WAS ACHIEVED, THE SURGEON PROCEEDED TO CLOSE THE INCISION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    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 E4KZ81

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR| HANDPIECE