BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24656993 · Received March 21, 2026

    Report

    Report Number
    2955842-2026-16716
    Event Type
    Injury
    Date Received
    March 21, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 21, 2026
    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
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL INC. TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH A HARD REBOOT AND THE SYSTEM POWERED BACK ON SUCCESSFULLY WITH NO ERRORS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A NON-RECOVERABLE ERROR APPEARED AND THE SYSTEM WOULD NOT POWER OFF. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH A HARD REBOOT AND THE SYSTEM POWERED BACK ON SUCCESSFULLY WITH NO ERRORS. THE TSE WAS UNABLE TO REVIEW THE SYSTEM LOGS AS THE SITE WAS NOT CONNECTED TO ONSITE. PRIOR TO CALLING THE TSE FOR ASSISTANCE, THE CUSTOMER HAD ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY FOR AN UNSPECIFIED REASON. 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
    24772 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A 00886874110898

    Patients

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