BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 24580384 · Received March 12, 2026

    Report

    Report Number
    2955842-2026-15797
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 11, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT AN ERROR C-00 OCCURRED ON THE ERBE GENERATOR DURING SYSTEM POWER-ON SELF-TEST. INITIALLY, THE USER ATTEMPTED TO RESOLVE THE ISSUE BY POWER CYCLING THE GENERATOR, BUT THE ERROR PERSISTED. THE TSE TRIED TO REVIEW ERROR LOGS, BUT THE ONSITE CONNECTION WAS NOT POSTING DUE TO INTERNET ISSUES IN THE THEATER. LATER, USER CALLED BACK AND REPORTED THAT THE ERROR C-00 WAS PERMANENT, AND TROUBLESHOOTING STEPS GUIDED VIA VIDEO DID NOT RESOLVE THE ISSUE. THE USER HAD A THIRD-PARTY ENERGY ACTIVATION CABLE BUT ONLY AN FT10, WHICH IS NOT VALIDATED FOR USE WITH THE DA VINCI SYSTEM. CONSEQUENTLY, THE USER DECIDED TO START THE CASE LAPAROSCOPICALLY, AND THE SYSTEM WAS MARKED AS DOWN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-10 N/A 00886874115343

    Patients

    Seq Age Sex Outcome Treatment
    1