BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE INSERT

    MDR report key: 2080467 · Received May 6, 2011

    Report

    Report Number
    2955842-2011-00137
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 11, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE CURVED BLADE TO BE BROKEN AT THE DISTAL END WITH A 0.415 INCH BY .085 INCH PIECE DETACHED. THE BLADE FRACTURED SLIGHTLY ABOVE THE STRAIGHT TO CURVED TRANSITION POINT. THE BROKEN PIECE EXHIBITS VARIOUS SCRATCH AND GOUGE MARKS ON THE SIDE THAT MAKE CONTACT WITH THE CLAMP ARM. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: "HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS." DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S COLORECTAL PROCEDURE, WHILE THE SURGEON WAS USING THE HARMONIC CURVED SHEARS INSTRUMENT WITH THE HARMONIC ACE INSERT, THE TIP BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED AND THE INSTRUMENT WAS REPLACED WITH ANOTHER INSTRUMENT OF THE SAME TYPE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, INJURY OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 M10100910

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES