BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22868174 · Received August 21, 2025

    Report

    Report Number
    2955842-2025-34985
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 30, 2025
    Report Date
    July 30, 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
    LA, US
    Reporter Occupation
    003

    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. FIELD SERVICE ENGINEER (FSE) REPLACED INTEGRATED ELECTROSURGICAL UNIT PART NUMBER 951300-03 DUE TO REPEATING ERROR C-37. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE INTEGRATED ELECTROSURGICAL UNIT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT GENERATOR WAS ANALYZED AND FOUND THE REPORTED ISSUE COULD NOT BE REPLICATED THROUGH SYSTEM LOGS. VISUAL INSPECTION REVEALED NO RELATED ISSUES. THE ERBE TESTED SUCCESSFULLY, ENERGIZING AND CAUTERIZING ALL PORTS AND INSTRUMENTS WITHOUT PROBLEMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ERBE HAD ERRORS AND REPLACED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408234 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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