BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24490303 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14705
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874123447
    PMA / PMN Number
    K241814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INSTRUMENT; HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, AND IT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT PASSED ENERGY DELIVERY AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND 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 AT THE DISTAL WRIST. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO DAMAGE. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE JAWS OF SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE NOT MOVING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WHILE THE SURGEON WAS USING THE SURGEON CONSOLE'S HIGH RESOLUTION STEREO VIEWER AND ATTEMPTING TO MANIPULATE INSTRUMENTS, WITH THE INSTRUMENT NOT MOVING AS DESIRED AND THE COAGULATION FUNCTION WAS NOT WORKING. THE INSTRUMENT DID NOT EXHIBIT SHAKINESS OR FRICTION, AND THERE WAS NO INTERFERENCE OR COLLISION WITH OTHER INSTRUMENTS OR SYSTEM ARMS. THE PROBLEM WAS RESOLVED BY REPLACING THE INSTRUMENT, WHICH THEN FUNCTIONED CORRECTLY, INDICATING THE ISSUE WAS LIKELY WITH THE INSTRUMENT ITSELF RATHER THAN THE DRAPE OR OTHER SYSTEM COMPONENTS. NO PATIENT INJURY OCCURRED, AND THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO VISIBLE DAMAGE. THE INSTRUMENT IS AVAILABLE FOR RETURN FOR EVALUATION, BUT NO PHOTOGRAPHIC OR VIDEO EVIDENCE IS AVAILABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516175 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430151-02 K10250515 0018 00886874123447

    Patients

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