BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE DRIVER FOR DAVINCI S

    MDR report key: 2172282 · Received July 11, 2011

    Report

    Report Number
    2172282
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 11, 2011
    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

    DAVINCI ROBOTIC 5MM NEEDLE DRIVER TIP BROKE IN THE PATIENT'S ABDOMINAL CAVITY DURING THE PROCEDURE. THE SURGEON ASKED FOR ANOTHER AND THE SECOND TIP ALSO BROKE. ALL PIECES OF BROKEN TIPS VISUALIZED AND RETRIEVED BY MD.======================MANUFACTURER RESPONSE FOR ENDOWRIST NEEDLE HOLDER 5MM INSTRUMENT, NEEDLE DRIVER FOR DAVINCI S (PER SITE REPORTER)======================NOTHING YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE DRIVER FOR DAVINCI S ENDOWRIST NEEDLE HOLDER 5MM INSTRUMENT NAY INTUITIVE SURGICAL, INC 420117 S1009116 (931) S10090701 (655

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NO OTHER THERAPIES