BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22501912 · Received July 14, 2025

    Report

    Report Number
    2955842-2025-29563
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 24, 2025
    Report Date
    November 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE
    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. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO MULTIPLE ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE ERBE. COMPLAINTS ARE TRACKED VIA THE QMS PROCESSES PER WI 859369 (QUALITY DATA REVIEW MEETINGS).

    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 GENERATOR WAS ANALYZED AND FOUND THE REPORTED ERBE ERROR COULD NOT BE CONFIRMED OR REPLICATED. NO RELATED DATA WAS FOUND IN THE ERROR LOGS, AND A VISUAL INSPECTION REVEALED NO ISSUES. THE UNIT FUNCTIONED NORMALLY DURING IN-HOUSE TESTING, WITH ALL PORTS OPERATING AS EXPECTED. THE UNIT WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER ANALYSIS AND POSSIBLE REPAIR. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS AND FIELD EVALUATION. THE PROBABLE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED AS THE ISSUE WAS NOT REPRODUCED DURING THE FSE SITE VISITED AND FAILURE ANALYSIS. THIS ISSUE WAS RESOLVED BY REPLACING THE ERBE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE HAD MULTIPLE ERRORS. ONSITE LOGS REFLECTED ERROR M-32 ERRORS. TECHNICAL SUPPORT ENGINEER (TSE) EXPLAINED THE ERROR POINTED TO MULTIPLE ENERGY ACTIVATION REQUESTS. EARLIER LOGS REFLECTED ERRORS THAT APPEAR TO BE CABLE, INSTRUMENT OR SET UP RELATED. 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
    426604 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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