BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21728901 · Received March 31, 2025

    Report

    Report Number
    2955842-2025-12139
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    February 14, 2025
    Report Date
    February 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. HOWEVER, THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC PROCEDURE AFTER PORT PLACEMENT. THE INTEGRATED TABLE MOTION (ITM) IS A THIRD PARTY PRODUCT. THIS MEDWATCH REPRESENTS THE CONVERSION FROM ROBOTIC TO LAPAROSCOPIC. SEE SECTION H10 FOR THE REPORTED BURN TO THE SURGEON'S THUMB. SECTION D10 CONCOMITANT PRODUCTS: HILLROM INTEGRATED TABLE MOTION ROBOTIC OPERATING TABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION PROCEDURE, THE INTEGRATED TABLE MOTION (ITM) TABLE CAUGHT FIRE, RESULTING IN A MINOR BURN TO THE SURGEON. THE CAUSE OF THE FIRE IS UNKNOW; HOWEVER, THE SURGEON DOES NOT BELIEVE THAT A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS INCIDENT OCCURRED AFTER THE TRANSFER OF THE PATIENT TO THE ITM TABLE AND THE PLACEMENT OF PORTS. THE PATIENT WAS NOT INJURED. THE HOSPITAL WAS UNABLE TO PROVIDE DETAILS REGARDING ANY MEDICAL INTERVENTIONS THAT MAY HAVE BEEN PERFORMED OR THE SEVERITY OF THE SURGEON'S INJURY. CONSEQUENTLY, THE PATIENT WAS RELOCATED TO ANOTHER ROOM, AND THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009893 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES