BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1172294 · Received September 19, 2008

    Report

    Report Number
    2955842-2008-01287
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    September 18, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING DISCOVERED A BROKEN PITCH CABLE AND A BROKEN WIRE AT THE YAW PULLEY EXIT, WHERE A PIECE OF MATERIAL IS ALSO MISSING. ENGINEERING ALSO OBSERVED DEEP SCRATCHES ON A LARGE AREA AROUND THE MAIN TUBE, WHERE MATERIAL HAS BEEN REMOVED. THE SCRATCHES EXTEND APPROXIMATELY 1.750" FROM THE INTERSECTION WITH THE PROXIMAL CLEVIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. DUE TO THE DAMAGE OBSERVED ON THE MAIN TUBE, IT'S POSSIBLE THAT THE WIRE AND PITCH CABLE BREAKAGES MAY HAVE ALSO BEEN A RESULT OF INSTRUMENT COLLISIONS. 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 TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE JAWS OF THE PK DISSECTING FORCEPS INSTRUMENT WOULD NOT CLOSE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED, AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 S10080707 195

    Patients

    Seq Age Sex Outcome Treatment
    1 AN ELECTROSURGICAL UNIT| ACCESSORIES| DA VINCI S SURGICAL SYSTEM