BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22878597 · Received August 22, 2025

    Report

    Report Number
    2955842-2025-35507
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 1, 2025
    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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND VISUAL INSPECTION-EXTERNAL, VISUAL INSPECTION-INTERNAL, MANUAL ARTICULATION OF INPUTS, ENERGY DELIVERY, ELECTRICAL CONTINUITY, RECOGNITION, ENGAGEMENT, AND INTUITIVE MOTION TESTS/ INSPECTIONS WERE PERFORMED AND THE COMPLAINT COULD NOT BE REPRODUCED. THE INSTRUMENT PASSED ENERGY DELIVERY TESTING IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST FAILURE ANALYSIS COULD NOT VERIFY THE CUSTOMER REPORTED EVENT. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS FOUND. THE COMPLAINT REGARDING A DAMAGED BLACK CORD WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLAINT IS NOT DETERMINABLE SINCE THE ISSUE WAS NOT CONFIRMED OR REPRODUCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING; THE FENESTRATED BIPOLAR FORCEPS HAD A DAMAGED BLACK CORD. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DAMAGE WAS NOTED AT THE BEGINNING OF REPROCESSING. THE INSTRUMENT HAD THE CORD MELTED AND SIGNS OF THERMAL DAMAGE. NO ARCING WAS SEEN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656725 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K12250529 0177 00886874119808

    Patients

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