BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL DA VINCI XL

    MDR report key: 6689032 · Received July 3, 2017

    Report

    Report Number
    MW5070807
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 3, 2017
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY AND BILATERAL PELVIC PUMP LYMPH NODE DISSECTION WITH ANTERIOR WITH ANTERIOR URETHROPEXY, ARM 4 OF THE DA VINCI XI SURGICAL ROBOT BECAME DISABLED AND WAS UNABLE TO BE RESTORED. SURGERY WAS COMPLETED USING THE REMAINING 3 ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464303 INTUITIVE SURGICAL DA VINCI XL SURGICAL COMPUTER INSTRUMENT NAY INTUITIVE SURGICAL, INC. SKO987

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR