BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22049725 · Received May 20, 2025

    Report

    Report Number
    2955842-2025-21031
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 26, 2025
    Report Date
    April 26, 2025
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY CUSTOMER RESEATING THE PARTS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ROBOTIC COORDINATOR (ROCO) CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT SITE WAS USING ERBE DEVICE IN OPEN SURGERY AND USING EXTERNAL CAUTERY PENCIL FOR DIATHERMY, BUT ENERGY SETTING COULD NOT BE CHANGED ON ERBE. TSE SUGGESTED CALLER REBOOT ERBE AND CHECK. CALLER CONFIRMED THE ISSUE REMAINED. TSE ADVISED THE CALLER TO USE EXTERNAL ENERGY SOURCE TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SITE WAS USING ERBE ENERGY IN OPEN SURGERY PROCEDURE. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142379 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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