BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ROBOT

    MDR report key: 10612974 · Received September 30, 2020

    Report

    Report Number
    MW5096981
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 28, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC-ASSISTED MYOMECTOMY, ROBOTIC ARMS STOPPED AND FROZE UP. THE SURGEON AND ASSISTED SURGEONS WERE AWARE. ATTEMPTED TO RELEASE INSTRUMENT WITH AN EMERGENCY KEY WITHOUT SUCCESS. DAVINCI REPRESENTATIVE WAS CALLED AND CONSULTED TO RESTART THE ROBOT. NO INJURY OCCURRED ROBOT RESTORED TO REGULAR FUNCTION WITHOUT ANY OTHER OCCURRENCE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068956 DA VINCI ROBOT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR