BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22780210 · Received August 12, 2025

    Report

    Report Number
    2955842-2025-33761
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE SYSTEM WAS VERIFIED AND READY FOR USE. .

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION: A REVIEW WITH A NURSE PRESENT ON THE DAY OF THE ARM MALFUNCTION CONFIRMED THAT ALTHOUGH THE INCIDENT WAS INITIALLY REPORTED AS OCCURRING DURING THE PROCEDURE BECAUSE THE PATIENT WAS ALREADY ANESTHETIZED, THE SURGERY HAD NOT STARTED, AND PORTS HAD NOT BEEN PLACED. THERE WAS NO HARM TO THE PATIENT DURING THIS SURGERY. ON ALL SUBSEQUENT OCCASIONS, THE ERROR OCCURRED BEFORE THE SURGERY BEGAN AND BEFORE PORT PLACEMENT, ALLOWING SURGERIES TO BE SCHEDULED SPECIFICALLY WITH ONLY THREE ARMS. NONE OF THE PATIENTS INVOLVED IN THESE SURGERIES EXPERIENCED HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE PREVIOUSLY REPORTER RECOVERABLE ERROR 32056 REOCCURRED, AND THE USER DISABLED THE UNIVERSAL SURGICAL MANIPULATOR (USM)2 TO RESOLVE THE ISSUE. THE USER CONTINUED WITH THE PROCEDURE USING THE REMAINING 3 USMS WITHOUT FURTHER ISSUES. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE ON (B)(6) 2025 WAS DETECTED DURING PROCEDURE AND THEY HAD TO DISABLE THE ARM AND COMPLETE THE PROCEDURE WITH 3 ARMS. AFTER THIS EVENT, THE ERROR APPEARED AGAIN EVERY TIME THE SYSTEM WAS TURNED ON FOR THE NEXT 3 SURGERIES (ONE ON THE SAME DAY AND TWO ON THE NEXT DAY).

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339664 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-43 N/A 00886874110720

    Patients

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