BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24692033 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18046
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED PARTS TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND FOUND THAT THE ISSUE COULD NOT BE CONFIRMED USING ARTEMIS. VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITIES RELATED TO THE REPORTED EVENT. FUNCTIONAL TESTING WAS PERFORMED USING THE SYSTEM PLATFORM, AND THE UNIT POWERED ON AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE. A REVIEW OF THE ERBE INTERNAL LOG REVEALED ERROR C#84.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ERBE POWER CORD TO THE OUTLET HAD A POP COMING FROM THE ERBE AND SMELLED SMOKE. PRIOR TO CALLING SHE UNPLUGGED THE TOWER AND ERBE AND PLACED THE TOWER IN THE HALLWAY. SITE WAS ELECTING TO MOVE THEIR PROCEDURES TO ANOTHER DV SYSTEM UNTIL THIS TOWER CAN BE INSPECTED. FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449543 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 00886874110898

    Patients

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