BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22987289 · Received September 6, 2025

    Report

    Report Number
    2955842-2025-37188
    Event Type
    Malfunction
    Date Received
    September 6, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 27, 2025
    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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. THE FSE WENT ON-SITE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; 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) 2 FOR FAILURE ANALYSIS INVESTIGATION. THE USM 2 WAS ANALYZED AND IN LOG REVIEWS, THE 23118 ERROR WAS FOUND INDICATING AN ENCODER FAULT ON THE USM PITCH AXIS, CONFIRMING THE FAULT 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 23118 ERROR WAS TRIGGERED, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE SENSOR CHECK WAS FOUND TO BE FAILING ON THE PITCH AXIS. ONCE TESTING WAS COMPLETED, THE PITCH CVA PRINTED CIRCUIT ASSEMBLY (PCA) WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE PROBABLE ROOT CAUSE OF THE REPORTED 23118 ERROR ON THE USM PITCH AXIS WAS IDENTIFIED AS A FAULT IN THE PITCH CVA PCA. THIS CONCLUSION WAS REACHED AFTER CONFIRMING AND REPLICATING THE ERROR IN THE FIELD AND DURING TESTING ON A GOLDEN SYSTEM AND PFTP, WHERE THE SENSOR CHECK FAILED ON THE PITCH AXIS. THE ABA TESTING OF THE PITCH CVA PCA VERIFIED IT AS THE SOURCE OF THE FAULT, LEADING TO THE DETERMINATION THAT THE PITCH CVA PCA WAS THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, REPEATED RECOVERABLE ERROR 23118 OCCURRED WHEN THE ENDOSCOPE WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE FOUND MULTIPLE ERRORS 23118 IN THE LOGS POINTING TO USM 2 AXIS 2. THE TSE HAD THE CUSTOMER PERFORM EMERGENCY POWER OFF (EPO), BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER ELECTED TO CONTINUE THE PROCEDURE WITH THE REMAINING THREE USM ARMS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. AFTER THE PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED TSE TO INFORM THAT THE CUSTOMER WAS UNABLE TO ADJUST THE BOOM HEIGHT WITH ¿VERTICAL JOINT LIMIT¿ MESSAGE ON USM 2. THE TSE ADVISED THE CUSTOMER TO EXERCISE USM 2 AS VERTICAL AXIS AND THEN PERFORM A HARD POWER CYCLE ON THE PATIENT SIDE CART (PSC).INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH THE REMAINING THREE USM ARMS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236677 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

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