BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24695750 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-18658
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 27, 2026
    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
    NE, US
    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 COMPLAINT. THE FSE FOUND THE INSERTION LINEAR RAIL SCREW BACKING OUT, PREVENTING CARRIAGE TRAVEL. THE FSE ALSO CONFIRMED ALL OTHER UNIVERSAL SURGICAL MANIPULATOR (USM) INSERTION RAILS SCREWS WERE TIGHT. THE USM WAS REPLACED TO RESOLVE THE ISSUE. THE FSE COMPLETED SYSTEM TEST DRIVE AND VERIFICATION AFTERWARDS WITHOUT FURTHER ISSUE. THE USM INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL BILATERAL INGUINAL HERNIA PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED FROM OFFSITE THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 2 CARRIAGE DID NOT RETURN DURING AN INSTRUMENT SWAP, AND ARM 2 STATUS WAS YELLOW. THE CALLER STATED THAT THE DRAPE WAS RESEATED AND THE SYSTEM WAS BEING POWER CYCLED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY. AT THIS TIME, IT IS UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED USING THE ORIGINAL CONFIGURATION. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER ENDED UP HAVING THE ASSISTANT HOLD THE MESH WITH A GRASPER AS A SUBSTITUTE TO THE MALFUNCTIONING ARM. THE ARM WAS NON-FUNCTIONAL. THE CUSTOMER HAD TO GET CREATIVE TO BE ABLE TO COMPLETE THE PROCEDURE. THEY WERE NOT ABLE TO USE ARM 2 AND IT WAS DISCONTINUED AFTER THE ERROR. THE ARM DID NOT MOVE AT ALL. IT DID NOT MOVE FREELY WITH UNCONTROLLED MOTION OR IN AN UNINTENDED DIRECTION. THE MOVEMENTS OF THE SURGEON DID NOT SCALE APPROPRIATELY TO THE ARM. THERE WAS NO DELAY IN MOVEMENT OR SHAKINESS RELATED TO THE ARM. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE HELP OF THE ASSISTANT HOLDING A GRASPER TO HELP FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58902 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1