BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23969126 · Received January 5, 2026

    Report

    Report Number
    2955842-2026-00039
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 11, 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
    NY, US
    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 EVENT. THE FSE WENT ON-SITE AND COULD REPLICATE THE ERROR. THE FSE THEN REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AND NO ERROR WERE FOUND. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND IN LOGS, THE ERROR 32101 WAS FOUND INDICATING ARM FRL HIT BECAUSE OF A HIGH-SIDE SWITCH ERROR ON USM 4 AXES CONTROL MOTOR (ACM), 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 AN IN-HOUSE SYSTEM WHERE THE ERROR 32101 WAS TRIGGERED, INDICATING ARM FRL HIT BECAUSE OF A HIGH-SIDE SWITCH ERROR (ACM), REPLICATING THE REPORTED PROBLEM. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE USM FAULT CHECK FAILED FOR 32101 AND THE DIRECTION TEST FAILED ON THE YAW AXIS. ONCE TESTING WAS COMPLETED, THE ACM PRINTED CIRCUIT ASSEMBLY (PCA) WAS TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE ACM IN THE USM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS HAVING RECOVERABLE FAULTS. TECHNICAL SUPPORT ENGINEER (TSE) VERIFIED 32101 IN LOGS. PRIOR TO CALLING IN, CUSTOMER DISABLED USM 4 TO CONTINUE WITH 3 ARMS, BUT WOULD LIKE THEIR FSE TO FOLLOW UP AS SOON AS POSSIBLE SINCE ARM 4 WAS JUST REPLACED. TSE SHARED ERROR WAS NOT THE SAME FROM RECENT REPLACEMENT. SITE TO POWER CYCLE AND HARD POWER CYCLE PATIENT CART AFTER PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478898 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A 00886874110720

    Patients

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