BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23480485 · Received November 5, 2025

    Report

    Report Number
    2955842-2025-44004
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 1, 2025
    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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS RETURNED FOR FAILURE ANALYSIS (FA). INSPECTION DURING THE FA PROCESS FOUND ISSUES THAT MAY RELATE TO THE REPORTED EVENT: M-B0 ERRORS LOGGED IN ERBE FROM 10/10/2025. UNIT TESTED ON SYSTEM, ALL INSTRUMENT RECOGNITION AND ENERGY OPERATION TESTS PERFORMED SUCCESSFULLY ON ALL PORTS.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY TO USE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    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 MYOMECTOMY PROCEDURE, THE CUSTOMER INDICATED THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT APPEARED TO BE DULL. AS A RESULT, THE CUSTOMER TURNED UP THE ERBE GENERATOR. AFTER DOING SO, THE CUSTOMER OBSERVED A 3CM BURN ON THE PATIENT'S RIGHT OUTER THIGH. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE AND SEVERITY OF THE BURN INJURY, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636628 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-27 N/A 00886874110898

    Patients

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