BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24476723 · Received February 27, 2026

    Report

    Report Number
    2955842-2026-14455
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO ERROR M-36. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE ERBE FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS ANALYZED AND THE ISSUE WAS CONFIRMED USING SYSTEM LOGS WHICH REVEALED ERROR M-36. A VISUAL INSPECTION DID NOT IDENTIFY ANY CONDITIONS RELATED TO THE REPORTED EVENT, AND SUBSEQUENT FUNCTIONAL TESTING CONFIRMED THAT THE UNIT POWERED ON NORMALLY AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE. ADDITIONALLY, A REVIEW OF THE INTERNAL ERBE ERROR LOG SHOWED THE PRESENCE OF M-36 AND M-B0. THE PROBABLE ROOT CAUSE OF ERROR M-36 IS ATTRIBUTED TO INSTALLATION ISSUES PREVENTING ENERGY ACTIVATION. THE INSTRUMENT MAY BE INSTALLED ON THE PATIENT SIDE CART ARM, BUT THE ENERGY CORD MAY NOT BE PROPERLY CONNECTED TO THE INSTRUMENT AND/OR GENERATOR. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT OCCURRED ON 11/26/2025 DURING THE PROCEDURE. THE CUSTOMER SWITCHED TO THE ESU GENERATOR FOR THE HANDPIECE BOVIE. THERE WAS NO INJURY TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE USING AN XI SYSTEM, THE CUSTOMER EXPERIENCED AN ERROR ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE SYSTEM DURING HANDHELD ENERGY ACTIVATION. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389297 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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