BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 1041303 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00259
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT HAD ZERO USES REMAINING, THEREFORE, WAS UNABLE TO CONDUCT PERFORMANCE TESTS ON A SYSTEM. MANUALLY ROTATING THE INPUT DISCS CONFIRMED THE INSTRUMENT MOVES INTUITIVELY WITH FULL RANGE OF MOTION, AND THE GRIPS OPEN AND CLOSE PROPERLY. ENGINEERING ALSO OBSERVED THE DISTAL END OF MAIN TUBE HAS VARIOUS DEEP SCRATCHES WITH MATERIAL REMOVED. SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS, SUGGESTING THEY WERE CAUSED BY INSTRUMENT COLLISIONS. INSTRUMENT IS FULLY FUNCTIONAL OTHERWISE. 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 DURING A DA VINCI S SURGICAL PROCEDURE, A LARGE NEEDLE DRIVER INSTRUMENT WAS NOT HOLDING THE NEEDLE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED, AND NO PIECES FELL INTO THE PT. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420006-05 0712102 369

    Patients

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