BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24984169 · Received April 24, 2026

    Report

    Report Number
    2955842-2026-22894
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 24, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874124055
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE PORT (SP) FORCE BIPOLAR INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS WAS NOT REPLICATED AND NOT CONFIRMED THE CUSTOMER COMPLAINT. THE SP FORCE BIPOLAR INSTRUMENT PASSED ELECTRICAL CONTINUITY. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT PASSED ENERGY DELIVERY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS RETESTED AND PASSED ALL IN-HOUSE TESTING ON BOTH ATTEMPTS. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PHYSICAL DAMAGE TO THE DISTAL WRIST. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND TO BE UNDAMAGED. NO PRODUCT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    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 FORCE BIPOLAR INSTRUMENT ELBOW AND WRIST WERE MOVING ERRATICALLY, AND THE SURGEON COULD NOT CONTROL THE MOTIONS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624092 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 431150-02 K11251106 0031 00886874124055

    Patients

    Seq Age Sex Outcome Treatment
    1