BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25143835 · Received May 11, 2026

    Report

    Report Number
    2955842-2026-24701
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 11, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A REPEATED RECOVERABLE FAULT ON ONE OF THE SYSTEM UNIVERSAL SURGICAL MANIPULATOR (USM) ARMS. THE CUSTOMER STATED THAT THE SYSTEM HAD BEEN RESTARTED MULTIPLE TIMES WITH NO CHANGE, AND THEN A HARD POWER CYCLE WAS PERFORMED ON THE POWER SYSTEM CONTROLLER DURING THE CALL, AFTER WHICH THE ERROR STILL RETURNED. THE CUSTOMER INDICATED THEY WERE CONTACTING THE SURGEON TO DETERMINE WHETHER THE PROCEDURE COULD PROCEED USING THREE ARMS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262084 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1