BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25074427 · Received May 4, 2026

    Report

    Report Number
    2955842-2026-23712
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 4, 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
    MS, US
    Reporter Occupation
    003

    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. FSE REPLACED THE PROXIMAL SETUP JOINT (PSUJ) DUE TO ERROR 32099 WHICH RESOLVED THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE PSUJ FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED. PROBABLE CAUSE OF ERROR 32099 POINTS TO ARM FAULT REACTION LOGIC (FRL) WAS HIT BECAUSE OF A HALF-BRIDGE DRIVER ERROR ON AC_4A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY KEPT GETTING A 32099 FAULT FOLLOWED BY A 23210 FAULT. THE TSE VERIFIED THE REPORTED ISSUES AND WALKED THE CUSTOMER THROUGH A HARD POWER CYCLE AND EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC). THE SYSTEM POWERED BACK ON WITH THE SAME ERRORS. THE CUSTOMER OPTED TO CONTINUE WITH THREE ARMS FOR THE DAY, AND THE TSE WALKED THE CUSTOMER THROUGH POSITIONING UNIVERSAL SURGICAL MANIPULATOR (USM4) AWAY FROM THE SURGICAL SITE AND DISABLING TO CONTINUE. THE CUSTOMER CONTINUED WITH THE SYSTEM USING THREE USMS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266651 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1