BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24370321 · Received February 17, 2026

    Report

    Report Number
    2955842-2026-04087
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    June 27, 2025
    Report Date
    April 21, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAW OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE GENERATOR AND PASSED BIPOLAR ENERGY RECOGNITION. THE INSTRUMENT WAS CONNECTED TO BIPOLAR CAUTERY CABLES ON AN IN-HOUSE SYSTEM AND PASSED ENERGY DELIVERY TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT RESPONDING TO THE SURGEON'S COMMANDS. 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 WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER (HRSV) WHILE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON SIDE CONSOLE (SSC). THE FENESTRATED BIPOLAR FORCEPS DID NOT MOVE IN THE INTENDED DIRECTION, SINCE THE INTENDED DIRECTION WAS RIGHT AND THE OBSERVED DIRECTION WAS DOWN. THE ISSUE WAS PERSISTENT. THE ISSUE WAS RESOLVED BY USING A BACKUP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506577 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K12250109 0155 00886874119808

    Patients

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