BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25009044 · Received April 27, 2026

    Report

    Report Number
    2955842-2026-22966
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 27, 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
    RO
    Reporter Occupation
    003

    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE. THE FSE REPLACED THE AXES CONTROLLER PLATFORM (ACP) AND THE AXES CONTROLLER PLATFORM BACKPLANE (ACPB); HOWEVER, SYSTEM ERROR 32100 WAS STILL PRESENT.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) HAS BEEN REQUESTED TO INVESTIGATE THE REPORTED EVENT. AT THIS TIME, THE FSE INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE SYSTEM HAD A 32100 FAULT. AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND NOTED 32100 FAULTS POINTING TO AXES CONTROLLER PLATFORM (ACP) 3. TSE ADVISED HARD POWER CYCLING THE SYSTEM TO SEE IF ERROR CLEARS. THE PROCEDURE WAS ABORTED WITH NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE REPORTER CONFIRMED THAT THE SYSTEM IS DOWN. SPARE PARTS ARE NEEDED TO PROCEED WITH THE REPAIR OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10678 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1