BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24407538 · Received February 20, 2026

    Report

    Report Number
    2955842-2026-05269
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 24, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE ISSUE WAS NOT REPLICATED DURING FAILURE ANALYSIS TESTING OF THE RETURNED PART, THE ERROR OBSERVED IN THE SYSTEM LOGS INDICATE A POTENTIAL ISSUE WITH THE MASTER TOOL MANIPULATOR (MTM) SENSOR.

    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 REPLACED MASTER TOOL MANIPULATOR (MTM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. THE MTM HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. THE REPORTED RECOVERABLE ERRORS ON THE MTM WERE CONFIRMED BUT NOT REPRODUCED. LOG REVIEW REVEALED ERROR 23027 (DIGITAL POT HEALTH STATUS ERROR, JOINT 3 C-BALANCE CABLE), CONFIRMING THE ISSUE OCCURRED IN THE FIELD. VISUAL INSPECTION FOUND NO RELEVANT ISSUES, AND MTM2 FUNCTIONED NORMALLY WITH ALL TESTS PASSING WITHIN SPECIFICATION. NO FAULTS WERE IDENTIFIED DURING INSPECTION AFTER TESTING.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE USING AN XI SYSTEM, AN OPERATING ROOM (OR) STAFF CALLED TO REPORT THAT UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 4 BECAME DISABLED AND THE SURGEON LOST CONTROL OF THE RIGHT MASTER TOOL MANIPULATOR (MTMR). ALTHOUGH THE CUSTOMER HAD ALREADY POWER CYCLED THE SYSTEM, THE ERROR RECURRED AT STARTUP. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED A HARD POWER CYCLE OF BOTH THE SURGEON SIDE CONSOLE (SSC) AND PATIENT SIDE CART (PSC), BUT THE ISSUE PERSISTED AND NO BACKUP SSC WAS AVAILABLE. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY, WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527301 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24 N/A 00886874110744

    Patients

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