BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI ROBOT FIREFLY FEATURE

    MDR report key: 16132128 · Received January 9, 2023

    Report

    Report Number
    MW5114240
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 5, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIOR TO ENTERING OR(OPERATING ROOM), PATIENT RECEIVED 5MG INDOCYANINE GREEN IN PRE-OP AREA PER SURGEONS' REQUEST IN ORDER TO VISUALIZE BILIARY AND CYSTIC STRUCTURES WITH THE FIREFLY FEATURE ON THE DAVINCI XI ROBOT . PATIENT WAS INTUBATED AND PREPPED FOR GALLBLADDER REMOVAL VIA ROBOTIC SURGERY. THE FIREFLY FEATURE WAS ENABLED ON ROBOTIC DISPLAY, AND NO FLUORESCENCE WAS NOTED TO DISCERN CYSTIC AND BILIARY STRUCTURES AFTER MORE THAN 100 MINUTES OF ICG BEING GIVEN. AN ADDITIONAL 2.5MG OF ICG WAS ADMINISTERED, AND NO FLUORESCENCE WAS SEEN ANYWHERE IN THE FIELD, INCLUDING BLOOD VESSELS. THE ROBOTIC CAMERA WAS CHANGED AND SOFTWARE TROUBLESHOOTED BY DAVINCI REPS WITHOUT VISUALIZATION OF GREEN FLUORESCENCE. SURGICAL PROCEDURE WAS COMPLETED WITHOUT UNDO HARM TO THE PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204972 DAVINCI XI ROBOT FIREFLY FEATURE SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female