BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21895756 · Received April 23, 2025

    Report

    Report Number
    2955842-2025-16466
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 31, 2025
    Report Date
    March 31, 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
    MI, 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. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO REPRODUCE AND CONFIRM THE REPORTED COMPLAINT. C-34 ERROR APPEARED UPON TESTING THE IESU ON AN IN-HOUSE SYSTEM IN NORMAL MODE. C-34 ERROR OCCURRED DURING STARTUP AND ENERGY ACTIVATION. UPON VISUAL INSPECTION, THE IESU HAD NO SIGNIFICANT SCRATCHES OR DENTS. THE IESU WILL BE RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER.

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, "ENERGY ACTIVATION HAS BEEN INTERRUPTED DURING SURGERY" MESSAGE APPEARED ON VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU). SITE RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). TSE ADVISED SITE TO USE A BACKUP ESU TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED 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
    675078 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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