BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3203668 · Received July 3, 2013

    Report

    Report Number
    2955842-2013-02405
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. ONE GRIP CLOSE CABLE WAS LOOSE AT THE DISTAL IDLERS. UPON OPENING UP THE HOUSING, THE SAME CABLE WAS FOUND BROKEN. THE BROKEN CABLE INSIDE THE HOUSING CAUSED THE LOOSE TENSION AT THE INSTRUMENT TIP AREA. THERE WAS ALSO AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY. ENGINEERING CONCLUDED IT WAS MOST LIKELY DUE TO MISHANDLING. AN ADDITIONAL FINDING WAS THE DISTAL END OF THE MAIN TUBE HAD A SCRATCH MARK SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCH WAS SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE 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 BROKEN CABLE AND TUBE ABRASIONS WITH MATERIAL REMOVAL , FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TOTAL HYSTERECTOMY PROCEDURE, A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT CABLE WAS IN A LOOP. 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
    304508 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120829 588

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES