BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 1191242 · Received September 26, 2008

    Report

    Report Number
    2955842-2008-01295
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED PERFORMANCE TESTS AND FOUND THAT ONE GRIP IS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS WITH A .045" OFFSET AT THE TIPS. THE BENT GRIP HAS SEPARATION OF THE YAW PULLEY AND CONDUCTOR CAP AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ELECTRICAL CONTINUITY PASSED. ENGINEERING ALSO OBSERVED A DEEP SCRATCH THAT IS APPROX .240" X .150" IN SIZE LOCATED NEAR A SECOND, NARROWER, SCRATCH OF APPROX .550" LONG. THE SCRATCHES ARE NEAR THE INTERSECTION OF THE PROXIMAL CLEVIS WHERE MATERIAL OF THE MAIN TUBE WAS REMOVED. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. 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 TIPS OF THE PK DISSECTING FORCEPS INSTRUMENT DO NOT MEET. NO ADD'L 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 ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420227-02 S10080711 524

    Patients

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