BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21878992 · Received April 22, 2025

    Report

    Report Number
    2955842-2025-16268
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 27, 2025
    Report Date
    March 27, 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
    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE COMPLAINT AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE IESU TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM REPORTED COMPLAINT VIA SYSTEM LOGS AND REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. DURING VISUAL INSPECTION, FA FOUND THE UNIT HAD NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL WAS IN DECENT CONDITION. THE UNIT WAS PLACED ON GOLDEN SYSTEM AND WAS RUN IN NORMAL MODE. C-34 ERROR OCCURRED ON START-UP AND DURING MONO COAG. FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    THE PROBABLE CAUSE OF ERROR C-34 IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE ERBE GENERATOR. THIS ERROR INDICATES A LOWER VOLTAGE THAN EXPECTED DURING ENERGY ACTIVATION. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM, AND IT POWERED ON WITHOUT ERRORS. THERE WAS NO ERROR WHEN THE GENERATOR WAS BOOTED UP IN THE MORNING, BUT WHEN STARTING TO USE, THERE WAS AN ERROR. THE CUSTOMER EXCHANGED THE GENERATOR FOR ANOTHER ONE TO COMPLETE THE PROCEDURE. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE ERBE GENERATOR HAD ERROR C-00 THAT OFTEN OCCURRED AND REBOOTING THE SYSTEM AND THE GENERATOR DID NOT RESOLVE THE ISSUE. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOG AND FOUND ERROR C-34 LOGGED MANY TIMES. AT THIS TIME, IT IS UNKNOWN IF THE CUSTOMER USED A THIRD-PARTY GENERATOR OR CONVERTED TO ANOTHER DA VINCI SYSTEM TO COMPLETE THE PROCEDURE. 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
    911611 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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