BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL, INC.

    MDR report key: 1733910 · Received June 22, 2010

    Report

    Report Number
    1733910
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERMANENT CAUTERY SPATULA WAS INSERTED THROUGH A TROCAR SLEEVE IN THE NORMAL FASHION, INTO CHEST CAVITY DURING ROBOTIC ASSISTED CORONARY ARTERY BYPASS GRAFT SURGERY. WHEN THE DEVICE WAS RETRACTED BACK INTO THE CAMERA VIEW, IT WAS NOTED THAT THE TIP OF THE CAUTERY SPATULA WAS BROKEN OFF THE DEVICE. X-RAY WAS TAKEN, THEN C-ARM WAS BROUGHT INTO THE ROOM. THE DEVICE WAS DETECTED ON BOTH TYPES OF X-RAY. OPERATION RESUMED AS PLANNED AND THE PIECE WAS RETRACTED AND SAVED. THE TOTAL TIMING OF ADDED SEARCH WAS 80 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTUITIVE SURGICAL, INC. PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC. DAVINCI S 0805141 933

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR