BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI / INTUITIVE SURGICAL

    MDR report key: 2945961 · Received January 30, 2013

    Report

    Report Number
    2945961
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROBOTIC INSTRUMENT WAS NOTED TO HAVE BROKEN DURING LAPAROSCOPIC ROBOTIC ASSISTED SURGERY, WIRES FROM THE INSTRUMENT WERE SEEN FRAYED INSIDE PT AND A SMALL PIECE OF METAL WIRE WAS REMOVED BY SURGEON. AN X-RAY WAS PERFORMED AT THE END OF THE CASE TO CONFIRM NO OTHER FOREIGN MATERIAL WAS LEFT INSIDE. NO FOREIGN ITEM SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41384 DAVINCI / INTUITIVE SURGICAL MEGA SUTURECUT NEEDLE DRIVER NAY INTUITIVE SURGICAL INC. 420309 M10121008955

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention