BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 24370928 · Received February 17, 2026

    Report

    Report Number
    2955842-2026-04122
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 22, 2026
    Report Date
    April 13, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE UNIVERSAL SURGICAL MANIPULATOR (USM) TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE AND DID NOT CONFIRM THE REPORTED COMPLAINT. 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 COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PATIENT FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, ALL SEARCHLIGHT, CHIP VIRTUAL ENCODER (CVA) AND HALL SENSOR ASSEMBLIES WERE INSPECTED, BUT NO FAULTS COULD BE IDENTIFIED. THE CARRIAGE GEARBOX WILL BE REPLACED AS A PRECAUTION TO THE REPORTED PROBLEM.

    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 WAS INFORMED THE REPORTED ISSUE OCCURRED WHEN RELEASING/PRESSING THE TWO KNOBS FROM DETACHING THE INSTRUMENT. THE INSTRUMENT WOULD THEN TURN 90-DEGREES AND WOULD MAKE IT IMPOSSIBLE TO RETRACT THE INSTRUMENT THROUGH THE CANNULA. THE FSE WAS INFORMED THE ISSUE HAD OCCURRED TO INSTRUMENTS WITHIN A FEW DAY INTERVALS. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE; HOWEVER, REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IMAGE REVIEW: REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE COMPLAINT. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE. NO FURTHER ESCALATIONS REQUIRED FOR THE IMAGE REVIEW.

    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 SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THAT IF AN INSTRUMENT WAS MOUNTED ON ARM 4, IT WOULD DIRECTLY GO TO A 90-DEGREE ANGLE AND WOULD NOT BE REMOVABLE. THE CSR INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THE ISSUE WAS ON GOING; HOWEVER, COULD NOT PROVIDE FURTHER INFORMATION. THE PROCEDURE WAS COMPLETED AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400050 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

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