BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S

    MDR report key: 2472123 · Received February 24, 2012

    Report

    Report Number
    2472123
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    INTUITIVE SURIGCAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    RN DRAPING THE ROBOT DISCOVERED HOLES IN THE 4 ARM CAMERA DRAPE. IT WAS DISCARDED FROM THE FIELD AND A NEW DRAPE OPENED. CASE PROCEEDED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S ACCESSORY, ROBOTIC SURGICAL, 4 ARM CAMERA DRAPE NAY INTUITIVE SURIGCAL, INC. * D113045

    Patients

    Seq Age Sex Outcome Treatment
    1 *