BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA

    MDR report key: 2110633 · Received May 26, 2011

    Report

    Report Number
    2110633
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 26, 2011
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT GYNECOLOGICAL SURGERY UTILIZING DA VINCI ROBOTICS. AN INTUITIVE CAUTERY SPATULA WAS UTILIZED DURING THE SURGERY. WHILE MOVING THE CAMERA AND THE CAUTERY SPATULA WITHIN THE ABDOMINAL CAVITY, THE TWO OBJECTS CAME IN CONTACT AND A SMALL PLASTIC PART WAS DISLODGED FROM THE TIP OF THE CAUTERY SPATULA. IT WAS NOT POSSIBLE TO IDENTIFY THE PIECE AND THE SURGEON ELECTED TO LEAVE IT IN THE ABDOMINAL CAVITY. THIS WAS THE INSTRUMENT'S FINAL USE.======================MANUFACTURER RESPONSE FOR ENDOWRIST MONOPOLAR CAUTERY INSTRUMENT, PERMANENT CAUTERY SPATULA (PER SITE REPORTER)======================THE REPRESENTATIVE WHO WORKS IN THE HOSPITAL WILL LET HIS SUPERVISOR KNOW ABOUT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA ENDOWRIST MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420184 10101007602 VER 05

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR