BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23042675 · Received September 12, 2025

    Report

    Report Number
    2955842-2025-36791
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 22, 2025
    Report Date
    August 22, 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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER WHO CONFIRMED THAT AFTER REMOVING THE DRAPE, IT WAS OBSERVED THAT THERE WAS A BROKEN PART AND WHICH COULD HAVE CAUSED THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON INFORMATION RECEIVED FROM THE CUSTOMER FROM FSE NOTES, THE SYSTEM ISSUE WAS DUE TO A DEFECTIVE DRAPE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE SITE CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT ISSUES THEY EXPERIENCED WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 3. IT WAS DIFFICULT TO MANIPULATE AND MADE THE OPPOSITE MOVEMENTS THAN WHAT THE SURGEON DID. THE SITE HAD THESE PROBLEMS ALREADY SEVERAL TIMES DURING THIS CASE AND WITH TWO DIFFERENT INSTRUMENTS ON THE SAME USM. THE TSE REVIEWED THE LOG AND NOTED THAT THEY WERE WORKING WITH TWO SURGEON SIDE CONSOLES (SSC). THE TSE ASKED TO MAKE SURE ALL INSTRUMENTS WERE GIVEN TO ONE SSC AND TAKEN BY THE OTHER. THE CUSTOMER SAID THAT WAS THE CASE, AND THE PROBLEM DID OCCUR ON BOTH SSCS. THE TSE ASKED IF THE AFFECTED INSTRUMENT(S) COULD BE TESTED ON ANOTHER USM. THE CUSTOMER INDICATED THAT BECAUSE OF THE ONGOING PROCEDURE IT WAS DIFFICULT TO DO SO. THEY WERE USING A THIRD INSTRUMENT ON USM 3 AND THAT WAS WORKING FINE, BUT THERE WAS A DELAY SOMETIMES. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SSC'S HIGH RESOLUTION STEREO VIEWER WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SSC. THERE WERE NO EXTERNAL COLLISIONS. THE ISSUE WAS INTERMITTENT. THE ISSUE OCCURRED WHEN TISSUE DISSECTION WAS BEING PERFORMED WITH BOTH INSTRUMENTS. THE ISSUE SEEMED TO BE RANDOM ALTHOUGH ONLY OCCURRING ON USM 3. THE AFFECTED INSTRUMENTS WERE WORKING FINE ON THE OTHER USMS. IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170866 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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