BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23575095 · Received November 17, 2025

    Report

    Report Number
    2955842-2025-44657
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    February 13, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU); THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. DURING THE POWER-ON TEST, THE ERROR WAS FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU); THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. DURING THE POWER-ON TEST, THE ERROR WAS FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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 RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, A NON-RECOVERABLE ERROR WAS OBSERVED ON THE ERBE GENERATOR, ACCOMPANIED BY BLEEDING. THE ERROR COULD NOT BE RESOLVED, SO THE SURGICAL TEAM SWITCHED TO CLASSIC COAGULATION MODE INSTEAD OF SPRAY COAGULATION. THIS RESULTED IN LOWER OUTPUT AND MADE IT DIFFICULT TO CONTROL THE BLEEDING. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, IF THE BLEEDING WAS EXPECTED OR UNEXPECTED, THE BLOOD LOSS VOLUME ASSOCIATED WITH THE COMPLICATION, AND WHAT MEDICAL/SURGICAL INTERVENTION WAS RENDERED DUE TO THE BLEEDING. NEVERTHELESS, THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE CUSTOMER INDICATED THAT THEY HAVE NO ADDITIONAL INFORMATION REGARDING THE BLEEDING INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274027 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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