BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25263470 · Received May 23, 2026

    Report

    Report Number
    2955842-2026-26184
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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. THE UNIT WAS ANALYZED AND ISSUE COULD NOT BE REPRODUCED UPON TESTING. LOG REVIEW SHOWED ERRORS M-32, C-37, AND 2-8A, AND THE ERBE INTERNAL LOG ALSO RECORDED C-84, M-B0, AND M-32. FUNCTIONAL TESTING CONFIRMED NORMAL POWER-ON AND SUCCESSFUL CAUTERIZATION ACROSS PORTS/INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE USING AN XI SYSTEM, A CLINICAL SALES REPRESENTATIVE (CSR) CALLED TO REPORT A SYSTEM ISSUE ON BEHALF OF THE CUSTOMER. THE SURGEON STATED THAT DURING MULTIPLE PROCEDURES, THE LONG BIPOLAR GRASPER INSTRUMENT DID NOT DELIVER EXPECTED CAUTERY EFFECT EVEN WHEN THE EFFECT MODE WAS SET TO 8. THE CUSTOMER REPORTED THAT THIS ISSUE DID NOT OCCUR WHEN USING THE SAME INSTRUMENT TYPE ON ANOTHER SYSTEM (SK4419). THE CSR DID NOT HAVE DETAILS ON TROUBLESHOOTING STEPS PERFORMED OR WHETHER THE ISSUE OCCURRED WITH OTHER BIPOLAR INSTRUMENTS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND NO DEPENDENT SERIAL NUMBERS RECORDED FOR THE LONG BIPOLAR GRASPER INSTRUMENTS USED ACROSS MULTIPLE DAYS AND NO ERBE-SPECIFIC ERRORS. AT THIS TIME, IT IS UNKNOWN HOW THE PROCEDURE PROCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551176 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1