BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 23802846 · Received December 15, 2025

    Report

    Report Number
    2955842-2025-48058
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    January 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    IZI
    UDI-DI
    00886874122228
    PMA / PMN Number
    K212101
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE CAMERA WAS FOUND TO HAVE COMMUNICATION FAILURES BASED OFF LOG REVIEW BUT WAS NOT REPLICATED DURING IN-HOUSE TESTING. A REVIEW OF THE SYSTEM LOGS SHOWED 3 INSTANCES OF AN ERROR POINTING TO A COMMUNICATION ISSUE. THE FAILURES WERE NOT REPLICATED IN HOUSE. THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM FOR FUNCTIONAL TESTING AND PASSED. STEREO CALIBRATION, ENDOSCOPE FOCUS TEST AND COLOR RECOGNITION WAS PERFORMED AND PASSED. IMAGES WERE CLEAR, DE-WARPED AND NOT GRAINY. NO NOISE OR MOTION BLUR WAS SEEN. THE BUTTONS WERE FULLY FUNCTIONAL AND MOVED INTUITIVELY. FIRST ELECTRICAL DIAGNOSTIC TEST (EDT) PASSED. LEAK TESTS WERE PERFORMED AND PASSED. THE MANIFOLD MEMBRANE WAS INSPECTED WITH THE BORESCOPE PROBE AND NO PUNCTURES OR TEARS WERE FOUND. ADDITIONALLY, THE ENDOSCOPE WAS TESTED AND PLACED ON A DIAGNOSTIC TESTER OR EQUIVALENT BUT FAILED FUNCTIONAL TESTING DUE TO AN ELECTRICAL FAILURE. THE DIAGNOSTIC TESTER RESULT EXHIBITED A VOLTAGE ISSUE DUE TO EXPECTED RANGE NOT BEING MET.

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE CUSTOMER AND CONFIRMED THE SYSTEM WAS IN USE WITHOUT ISSUE AND DETERMINED THAT THE ISSUE WAS LIKELY ISOLATED TO THE ENDOSCOPE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOSCOPE MALFUNCTIONED, AND NO PICTURE WAS SEEN. THE CUSTOMER CALLED TECHNICAL SUPPORT BUT WERE NOT ABLE TO RESOLVE THE ISSUE. THE ENDOSCOPE FAILED THE SELF-TEST WITH A MESSAGE THAT THERE WAS NO VIDEO SIGNAL. SYSTEM LOGS WERE UNAVAILABLE FOR REVIEW AT THE TIME OF THE CALL TO TECHNICAL SUPPORT. THE CUSTOMER TRIED RESEATING THE ENDOSCOPE 5-6 TIMES WITH NO SUCCESS. THE CUSTOMER INSPECTED THE ENDOSCOPE CONNECTOR (EC) AND NOTED NO VISIBLE SIGNS OF DAMAGE. THE CUSTOMER ALSO TRIED CLEANING THE EC, AND PERFORMING A HARD REBOOT ON THE VISION SIDE CART (VSC) WITH NO CHANGE. THE CAMERA WAS NOT RECOGNIZED; THE SYSTEM PROMPTED TO CLEAN THE LENSES, BUT IT DID NOT WORK. FINALLY, THE CUSTOMER HAD TO CHANGE FROM SINGLE PORT (SP) TO MULTI-PORT XI TO FINISH THE PROCEDURE AFTER A DELAY OF GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790412 ENDOWRIST SP CAMERA, 0° IZI INTUITIVE SURGICAL, INC 430077-05 N/A 00886874122228

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.