BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21721111 · Received March 28, 2025

    Report

    Report Number
    2955842-2025-11742
    Event Type
    Injury
    Date Received
    March 28, 2025
    Date of Event
    February 28, 2025
    Report Date
    February 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA). A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM LOG ERRORS THAT WOULD INDICATE ANY ISSUES WITH THE SYSTEM OR ANYTHING RELATED TO THE COMPLAINT. A SYNCHROSEAL INSTRUMENT WAS USED IN THE PROCEDURE FOR 3 MINUTES 45 SECONDS. THERE WAS 1 COAG AND 24 TRANSECT EVENTS WERE NOTED IN THE E100 GENERATOR LOGS. THE SYSTEM LOGS SHOW NO SYNCHROSEAL INSTRUMENT RELATED ERRORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT COLECTOMY PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST THAT THE SURGEON BELIEVES WAS CAUSED BY AN UNDERLYING HEART CONDITION. DURING THE PROCEDURE, THE SURGEON DID NOT ENCOUNTER ANY PROBLEMS WITH THE DA VINCI SYSTEM OR ITS ACCESSORIES, AND THERE WERE NO ISSUES SUCH AS BLEEDING. THE PATIENT SURVIVED AND WENT FOR A CORONARY ANGIOGRAPH AND STENT PLACEMENT. THE FOLLOWING DAY, THE PATIENT UNDERWENT OPEN SURGERY TO COMPLETE THE PROCEDURE AND HAS SINCE BEEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614180 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| L| R DA VINCI INSTRUMENTS AND ACCESSORIES