BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 23526832 · Received November 11, 2025

    Report

    Report Number
    2955842-2025-44713
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 17, 2025
    Report Date
    December 4, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE SITE TO PRESS THE CLUTCH BUTTON ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 TO CANCEL THE GUIDED TOOL CHANGE (GTC) FUNCTION IN ORDER TO POSITION THE ENDOSCOPE MANUALLY; FOLLOWING THIS ACTION, THE ISSUE WAS RESOLVED AND NORMAL FUNCTIONALITY WAS RESTORED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO IMPROPER SYSTEM FUNCTIONALITY OF THE GTC FEATURE, RESULTING ON INCORRECT IMAGE ORIENTATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS REVERSED: THE INSTRUMENTS, WHICH ENTERED TO THE RIGHT OF THE CAMERA, APPEARED ON THE LEFT OF THE SCREEN. THE ENDOSCOPE WAS MOVED FREELY, UNDER THE CONTROL OF THE SURGEON. AFTER TECHNICAL SUPPORT ENGINEER INTERVENTION, WE CONTINUED THE PROCEDURE AS NORMAL (NO CONVERSION, NO SURGICAL MODIFICATIONS) WITH THE ROBOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE NURSE CALLED TO REPORT THAT IT HAD BEEN IMPOSSIBLE TO ACHIEVE THE DESIRED ENDOSCOPE ORIENTATION. INSTRUMENTS IN CONTROL AROUND THE ENDOSCOPE HAD BEEN COHERENT, BUT THE VIEW HAD APPEARED INVERTED COMPARED TO EXPECTATIONS. PRIOR TO THE CALL, THE SITE HAD ALREADY RESTARTED THE SYSTEM AND REPLACED THE ENDOSCOPE, BUT THE BEHAVIOR HAD PERSISTED AS SOON AS THE ENDOSCOPE HAD BEEN INTRODUCED. AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING SUPPORT. LOGS HAD BEEN REVIEWED, BUT NOTHING RELEVANT HAD BEEN FOUND. GUIDANCE HAD BEEN PROVIDED TO PRESS THE CLUTCH BUTTON OF UNIVERSAL SURGICAL MANIPULATOR (USM) 2 TO CANCEL THE GUIDED TOOL CHANGE (GTC) FUNCTION, WHICH HAD HELPED ENABLE MANUAL POSITIONING OF THE ENDOSCOPE. AN EXPLANATION HAD BEEN GIVEN THAT THIS FUNCTION ALLOWED THE USER TO REPOSITION THE ENDOSCOPE IN ITS ORIGINAL ORIENTATION, AND THIS INFORMATION HAD BEEN ACKNOWLEDGED. THE SITE HAD WISHED TO RETURN THE INITIAL ENDOSCOPE TO PLACE, AND THE GTC FUNCTION HAD HELPED ACHIEVE THE SAME POSITION. THE ISSUE HAD BEEN RESOLVED, AND THE SYSTEM HAD BEEN DECLARED READY FOR USE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951458 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-48 N/A 00886874115404

    Patients

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