BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24499783 · Received March 3, 2026

    Report

    Report Number
    2955842-2026-14641
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY SOLELY DUE TO THE PATIENT'S ANATOMICAL CHALLENGES, SPECIFICALLY DENSE AND EXTENSIVE ADHESIONS. THERE WERE NO INTRAOPERATIVE COMPLICATIONS OR ISSUES WITH THE SURGICAL SYSTEM ITSELF; THE ONLY TECHNICAL ISSUE NOTED WAS AN ARM COLLISION, BUT THIS DID NOT CONSTITUTE A SYSTEM MALFUNCTION AND DID NOT CONTRIBUTE TO THE NEED FOR CONVERSION. THE PATIENT TOLERATED THE CHANGE WELL, AND THERE WAS NO INJURY RESULTING FROM THE CONVERSION OR THE PROCEDURE ITSELF. THE SYSTEM WAS INSPECTED PRIOR TO USE AND FUNCTIONED NORMALLY, WITH NO ISSUES NOTED DURING SETUP. THERE WAS NO DEVICE MALFUNCTION, AND THE PATIENT EXPERIENCED NO HARM OR POST-OPERATIVE COMPLICATIONS. CONSEQUENTLY, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED AFTER THE PROCEDURE. THERE WAS NO VIDEO RECORDING AVAILABLE FOR INTUITIVE SURGICAL, INC. (ISI) REVIEW IN THIS CASE.

    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 WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE AND NO PRODUCTS WERE REPLACED. THE FSE INSPECTED/TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WANTED TO TAKE A PHOTO. THE CUSTOMER TRIED SEVERAL USBS AND ALL WERE NOT RECOGNIZED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VERIFIED THE USB PORT ON THE VIDEO PROCESSOR (VP) AND FOUND THAT IT TOOK MORE TIME TO RECOGNIZE THE USB DEVICE. THE SURGEON ELECTED TO CONVERT THE CASE 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
    205815 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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