BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3253396 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02822
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 13, 2013
    Report Date
    July 8, 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 CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS COULD STILL OPEN AND CLOSE, BUT MOVEMENT MAY NOT HAVE BE PRECISE. ADDITIONAL OBSERVATION NOT REPORTED WAS A FRAYED CABLE. ONE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. FRAYED MICRO-STRANDS STICK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE CABLE CAME OFF TRACK ON A MEGA SUTURECUT NEEDLE DRIVER 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
    352991 MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130326 145

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES