BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI

    MDR report key: 3842787 · Received May 13, 2014

    Report

    Report Number
    3842787
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 13, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    ROBOTIC CAMERA ARM LOST FUNCTIONALITY OF THE SCOPE AND CAMERA HEAD TWO HOURS INTO THE PROCEDURE. SCOPE WAS REMOVED, THE CASE WAS ABORTED AND COMPLETED LATER THE SAME DAY WHEN A REPLACEMENT ARM WAS OBTAINED BY THE VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285385 DA VINCI SI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. SH1041 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *