BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22486201 · Received July 11, 2025

    Report

    Report Number
    2955842-2025-29478
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 24, 2025
    Report Date
    June 24, 2025
    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
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED IN THE LOGS. UPON VISUAL INSPECTION THERE WERE NO ISSUES FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING SYSTEM. ON STARTUP, THE UNIT DISPLAYED ERROR C-34 AND THE DISTINCT BURNING SMELL OF PLASTIC WAS TRACED TO THE FUSE BOX. UPON VISUAL INSPECTION THE UNIT'S COVER IS SCRATCHED. OTHERWISE, THE UNIT IS IN GOOD CONDITION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO FAULTY ELECTRICAL COMPONENT ON THE FUSE BOX OF THE ERBE IESU. THIS ERROR CAN BE RESOLVED BY REPLACING THE GENERATOR.

    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT YET RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE, WHICH WAS RESOLVED BY FSE REPLACEMENT OF THE IESU.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NURSE CONTACTED TECHNICAL SUPPORT REPORTING A BURNING SMELL COMING FROM THE ERBE DURING A PROCEDURE. THE TECHNICAL SUPPORT ENGINEER REVIEWED THE SYSTEM'S EVENT LOGS AND IDENTIFIED FAULTY RECORDS RELATED TO THE ERBE, ERRORS M-11, M-18, C-30 AND C-34. THE ENGINEER INSTRUCTED THE NURSE TO CHECK THE ERBE'S POWER CABLE, WHICH WAS CONNECTED TO A LINE STRIP SHARED WITH OTHER EQUIPMENT. THE NURSE WAS ADVISED TO CONNECT THE POWER CABLE TO A DEDICATED CIRCUIT SOCKET FOR THE ERBE. DESPITE THIS CHANGE, THE BURNING SMELL PERSISTED UPON TURNING THE ERBE BACK ON. CONSEQUENTLY, THE ENGINEER INSTRUCTED THAT THE ERBE BE TURNED OFF AND RECOMMENDED USING A BACKUP CAUTERY TO CONTINUE THE PROCEDURE. THE MEDICAL TEAM PROCEEDED WITH THE BACKUP CAUTERY, AND THE PROCEDURE CONTINUED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE ESU HAD FUNCTIONED PROPERLY PREVIOUSLY DURING THE PROCEDURE. THE SYSTEM AND ESU FUNCTIONALITY WAS CHECKED UPON POWERING ON AND INITIALLY POWERED ON WITHOUT ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049278 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-44 N/A 00886874110898

    Patients

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