BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3112695 · Received May 14, 2013

    Report

    Report Number
    2955842-2013-01662
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENTS WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THERE WERE ALSO INDENTATIONS ON THE EDGE AND SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. ENGINEERING CONCLUDED IT WAS MOST LIKELY DUE TO MISHANDLING. AN ADDITIONAL FINDING NOT REPORTED WAS A SCRATCH MARK SHOWING LIGHT MATERIAL REMOVAL ON THE DISTAL END OF THE MAIN TUBE. ENGINEERING CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE THE WIRES OF THE ARTICULATION HAVE BEEN BROKEN ON THE LARGE NEEDLE DRIVER INSTRUMENT. THE PROCEDURE CONTINUED WITH ANOTHER INSTRUMENT. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213031 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10130123 622

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES