BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23993001 · Received January 7, 2026

    Report

    Report Number
    2955842-2025-50237
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 30, 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
    UK
    Reporter Occupation
    NURSE
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE USED TEST INSTRUMENTS AND TESTED THE SYSTEM AND RAN FULL UNIVERSAL SURGICAL MANIPULATOR (USM) DATA TERMINAL EQUIPMENT (DTE) TEST AND NO ERRORS OR ISSUES WERE DETECTED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS DUE TO CONSTRUCTION AT THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE NURSE REPORTED TO THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE UNIVERSAL SURGICAL MANIPULATOR (USM1) WAS HAVING CONTINUOUS INVOLUNTARY SIDEWAYS MOVEMENT. THE MOVEMENT WAS SIDEWAYS. THE TSE GUIDED THE NURSE TO CHECK THE DRAPING OF THE USMS TO SEE IF THERE WERE ANY OBSTRUCTIONS IN ANY AXIS, THOUGH THE NURSE STATED THERE WERE NONE. THE TSE REVIEWED THE LOGS AND FOUND NO ERRORS RELATED TO ANY INVOLUNTARY MOVEMENT. DURING THE CALL, THE TSE WAS ASKED IF INVOLUNTARY TREMORS RELATED TO PARKINSON'S DISEASE COULD GENERATE THIS ISSUE, AND THE TSE CONFIRMED IT COULD. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON SIDE CONSOLE (SSC). NO EXTERNAL COLLISIONS WERE OBSERVED. THE ISSUE WAS INTERMITTENT. ACTION TAKEN WHEN THE ISSUE OCCURRED WAS ALL TEAMS MADE AWARE AND THEY CHECKED BOTH INTERNAL AND EXTERNAL FOR POTENTIAL COLLISIONS AND NONE WERE FOUND. THERE WERE NO PATTERNS IDENTIFIED WITH THE REPORTED ISSUE. THE ISSUE APPEARED TO RESOLVE ITSELF.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370430 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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