BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI S SURGICAL SYSTEM

    MDR report key: 1180743 · Received July 30, 2008

    Report

    Report Number
    1180743
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 30, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE INTUITIVE SURGICAL INC.'S DAVINCI S ROBOTIC SYSTEM IN AN ELECTIVE CORONARY BYPASS SURGICAL PROCEDURE, THE ROBOTIC CAMERA REMOTE CONTROL FUNCTION FAILED. THE REMAINDER OF THIS SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ROBOT, WITH MANIPULATION OF THE CAMERA ARM PERFORMED BY SURGICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI S SURGICAL SYSTEM ROBOTIC SYSTEM NAY INTUITIVE SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR