BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1203500 · Received October 17, 2008

    Report

    Report Number
    2955842-2008-01323
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND ONE CONDUCTOR WIRE BROKEN AT THE YAW PULLEY EXIT. THE YAW PULLEY SHOWS NO SIGNS OF ARCING, HOWEVER, THERE IS A .150 INCH BY .060 INCH PIECE OPPOSITE THE CONDUCTOR BREAK THAT IS MISSING ALLOWING THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN YAW. THE ADDED RANGE OF MOTION OF THE GRIP LIKELY CREATED EXCESS TENSION ON THE WIRE, CAUSING IT TO BREAK. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE A .800 INCH LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. A SECTION 90 DEGREES FROM THE TUBE ABRASION, JUST ABOVE THE PROXIMAL CLEVIS, VARIOUS DEEP SCRATCHES WERE FOUND. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS, SUGGESTING THEY WERE CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. ELECTRICAL CONTINUITY FAILED. NO OTHER DAMAGE WAS FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED. 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 THE SPRING CAME LOOSE ON THE PK DISSECTING FORCEPS INSTRUMENT. IT WAS NOTED THAT NOTHING FELL INTO A PT. NO ADDITIONAL INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 1509071 372

    Patients

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