BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 25330464 · Received May 29, 2026

    Report

    Report Number
    2955842-2026-25893
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, A POWER OUTAGE IN THE AREA SURROUNDING THE HOSPITAL CAUSED A LOSS OF POWER WITHIN THE FACILITY. THE DA VINCI SYSTEM EXPERIENCED AN UNRECOVERABLE FAILURE DUE TO THE ABSENCE OF UPS EQUIPMENT. ALTHOUGH THE SURGICAL TEAM WAITED FOR THE HOSPITAL'S GENERATOR TO RESTORE POWER, IT DID NOT COME ONLINE. AS TIME PASSED AND POWER REMAINED UNAVAILABLE IN THE OPERATING ROOM, THE DECISION WAS MADE TO CONVERT THE PROCEDURE TO OPEN SURGERY. THE ROBOTIC INSTRUMENTS WERE SUCCESSFULLY REMOVED USING THE INSTRUMENT RELEASE KEY (IRK). THE POWER WAS RESTORED APPROXIMATELY A COUPLE OF HOURS LATER. THE PATIENT TOLERATED THE CHANGE IN SURGICAL APPROACH, AND THE PROCEDURE WAS COMPLETED WITH A DELAY OF GREATER THAN 30 MINUTES. THE PATIENT DID NOT EXPERIENCE ANY POSTOPERATIVE COMPLICATIONS, THERE IS NO CONCERN FOR ANY LONG-TERM COMPLICATIONS, AND THE PATIENT HAS SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160482 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1