BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25263464 · Received May 23, 2026

    Report

    Report Number
    2955842-2026-26177
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 22, 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
    PA, 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 NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 4 KEPT FAULTING OUT AND THINKS IT WAS CONNECTED TO THE PATIENT. TSE REVIEWED THE LOGS AND FOUND 1162 FAULTS FOR USM 4 FOR THE CANNULA SENSE. PRIOR TO CALLING IN, THEY POWER CYCLED, AND THE FAULT CAME BACK ON AT POWER-ON. TSE HAD THEM HARD POWER CYCLE THE PATIENT CART, AND THE FAULT CAME BACK AGAIN AT POWER UP. THE CUSTOMER NEEDED ALL FOUR ARMS FOR THE CASE. SO, THEY PULLED IN ANOTHER PATIENT CART FROM A DIFFERENT SYSTEM TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527288 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1