BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21972633 · Received May 6, 2025

    Report

    Report Number
    2955842-2025-18924
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 15, 2025
    Report Date
    April 15, 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
    NY, US
    Reporter Occupation
    NURSE
    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. FSE REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE TO RESOLVE THE ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND VISUAL INSPECTION IDENTIFIED SCRATCHES ON TOP COVER. C-34 ERRORS ON START AND MONO COAG ACTIVATION. ERBE UNIT THAT WAS PLACED ON GOLDEN SYSTEM AND WAS RUN IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO GENERATOR DEFECT BASED ON VOLTAGE ERROR. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR ADDITIONAL FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    UPDATED ANNEX C - INV FINDINGS DESC 1 TO C0201 - ELECTRICAL/ELECTRONIC COMPONENT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE GENERATOR HAD A REPEATED ERROR C-34 WHEN APPLYING MONOPOLAR ENERGY. THE TECHNICAL SUPPORT ENGINEER CONFIRMED THE REPORTED ERROR IN THE LOGS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE CASE WAS COMPLETED WITH THE SAME ERBE GENERATOR; THE SURGEON CONTINUED THE CASE WITH THE AVAILABLE BIPOLAR ENERGY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832953 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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