BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21868743 · Received April 18, 2025

    Report

    Report Number
    2955842-2025-16216
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 28, 2025
    Report Date
    March 28, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND FOUND TO HAVE THE ERROR C-34 ON ERBE. SYSTEM LOGS SHOWED ERRORS 25913, C-34, C-30, AND M-11. VISUAL INSPECTION REVEALED A CRACKED BEZEL AT THE TOP LEFT CORNER. C-34 ERRORS OCCURRED AT STARTUP, WHILE C-30 AND M-11 ERRORS APPEARED DURING MONO CUT MODE. THE UNIT WAS TESTED ON A GOLDEN SYSTEM IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. 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.

    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 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. THIS ERROR CAN BE RESOLVED THROUGH TROUBLESHOOTING OR REPLACEMENT OF THE GENERATOR.

    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 INTEGRATED ELECTROSURGICAL UNIT (IESU) ERBE SHOWED ERROR MESSAGE C-34. THE CUSTOMER WAS GUIDED TO CHECK IF FUSE AND VOLTAGE ARE SET ACCORDING TO THE LOCAL MAINS VOLTAGE. THE CUSTOMER WAS ADVISED TO SET AN EXTERNAL ENERGY DEVICE, BUT THE MEDICAL TEAM DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THE SYSTEM COULD BE USED WITH AN EXTERNAL ENERGY DEVICE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THE PATIENT TOLERATED THE CONVERSION. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30387 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES