BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3022158 · Received March 26, 2013

    Report

    Report Number
    2955842-2013-00969
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED ONE GRIP CABLE WAS BROKEN AT THE DISTAL CLEVIS. THE BROKEN SEGMENT STUCK OUT APPROXIMATELY .1500 AT THE INSTRUMENT WRIST. THE IDLER PULLEY SPUN FREELY BUT ALSO SHOWED SOME WEAR. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. AN ADDITIONAL OBSERVATION FOUND WERE CORRODED BACK IDLER PULLEYS. THE BACK IDLER PULLEYS EXHIBITED CORROSION IN BETWEEN EACH PULLEY. THE IDLER PULLEYS WERE NOT SEIZED AND STILL ROTATED. DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A WIRE BROKE AT THE TIP OF THE LARGE 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
    124792 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10121203 942

    Patients

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