BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23079604 · Received September 17, 2025

    Report

    Report Number
    2955842-2025-38401
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 26, 2025
    Report Date
    August 26, 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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE IESU WAS ANALYZED AND FOUND NO VISUAL ISSUES. THE UNIT FUNCTIONED NORMALLY DURING TESTING. ERBE WILL BE SENT TO ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS BUT WAS CONFIRMED IN THE FIELD. THE PROBABLE ROOT CAUSE IN THIS CASE IS ATTRIBUTED TO THE FAULTY ERBE GENERATOR. THIS ERROR INDICATES THE UNABLE TO READ INSTRUMENT DATA ON PORT 1. THIS ISSUE CAN BE RESOLVED BY RELEASING THE ENERGY ACTIVATION PEDAL AND REACTIVATING IF ADDITIONAL ENERGY IS REQUIRED.

    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 LOW ANTERIOR RESECTION (LAR) AND BLADDER AUGMENTATION SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SECONDARY PORT ON THE ERBE WAS NOT WORKING, AND THEY CHANGED THE BLUE BIPOLAR CABLE AND THE 1-8A AND 2-8A ERROR CAME BACK. THE CUSTOMER POWER CYCLED THE ERBE, AND THE MESSAGE CAME BACK. THE CUSTOMER MOVED TO THE SECOND PORT DOWN AND THE MESSAGE DID NOT COME BACK. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577449 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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