BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23971277 · Received January 6, 2026

    Report

    Report Number
    2955842-2026-00082
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 15, 2025
    Report Date
    March 10, 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
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND THE ERROR 32056 WAS FOUND INDICATING FAILURE TO INITIALIZE I2C DEVICE POINTING TO THE PITCH, CONFIRMING THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERROR 32058 TRIGGERED INDICATING FAILURE TO INITIALIZE I2C DEVICE POINTING TO THE PITCH, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE THE AGC CURRENT TEST FAILED TRIGGERING A 32056-ERROR POINTING TO THE PITCH. ONCE TESTING WAS COMPLETED, THE PITCH SEARCHLIGHT FFC WAS A TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    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) 3. 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. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, A SURGEON CALLED IN BETWEEN TWO SURGERIES AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT A NON-RECOVERABLE ERROR 32056 ON UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 3. THE SURGEON HAD COMPLETED THE SURGERY WITH THREE ARMS AND PLANNED TO DO THE NEXT ONE WITH THREE ARMS AS WELL. A HARD POWER RESET HAD ALREADY BEEN PERFORMED. THE TSE CONFIRMED ERRORS POINTING TO USM3 IN THE LOGS AND GUIDED THE SURGEON THROUGH ANOTHER REBOOT WITH EMERGENCY POWER-OFF (EPO), BUT THE ERROR RETURNED. THE TSE EXPLAINED THAT ARM 3 NEEDED TO BE DEACTIVATED TO CONTINUE, AND THE SURGEON AGREED. THE NEXT SURGERY WAS SET TO START. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24126 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A 00886874110720

    Patients

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