BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23721648 · Received December 4, 2025

    Report

    Report Number
    2955842-2025-47372
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    October 22, 2025
    Report Date
    January 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. THE BROKEN PIECE MEASURES APPROXIMATELY 16.38MM X 4MM, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A DETACHED INTACT JAW FROM THE GRIP BASE. BASED ON VISUAL INSPECTION AND ANALYSIS OF THE RETURNED DEVICE. THE MOLDED INSULATOR BREAKS FIRST AND SEPARATING FROM THE JAW (ELECTRODE). THE JAW SUBSEQUENTLY SEPARATED FROM THE GRIP BASE DUE TO LOSS OF MECHANICAL SUPPORT FROM THE MOLDED INSULATOR, THE BIPOLAR CONDUCTOR WIRE BROKE AS A RESULT OF INCREASED MECHANICAL STRESS DURING JAW DETACHMENT. AS OF RESULT, THE INTACT JAW AND BROKEN MOLDED INSULATOR FULLY DETACHED FROM THE INSTRUMENT ASSEMBLY. THE COMPLAINT REGARDING TIP OF THE FORCE BIPOLAR IS BROKEN WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE BROKEN MOLDED INSULATOR IS ATTRIBUTED TO USER-RELATED DAMAGE RESULTING FROM MECHANICAL IMPACT OR THE APPLICATION OF EXCESSIVE FORCE TO THE JAWS, SUCH AS AN ACCIDENTAL DROP OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

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

    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 DIAGNOSTIC LAPAROSCOPY SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT TIP BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A BROKEN JAW ON THE ARM, NO MATERIAL WAS BROKEN OFF OR DETACHED IN THE PATIENT. THE JAW BROKE OFF AND FELL APART ONCE THE ARM WAS REMOVED OUT OF THE TROCAR, THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454557 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11250515 0150 00886874120767

    Patients

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