BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22652085 · Received July 29, 2025

    Report

    Report Number
    2955842-2025-32199
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 29, 2025
    Report Date
    July 9, 2025
    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
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR WAS ANALYZED AND FOUND TO HAVE A BROKEN CONDUCTOR WIRE WITHIN THE BIPOLAR YAW PULLEY, BETWEEN THE WIRE CRIMP ON THE GRIP AND THE SILICONE POTTING, WHICH SEALS THE WIRE ENTRANCE TO THE YAW PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. COMPONENTS ADJACENT TO THE BROKEN DO NOT SHOW DAMAGE. THE COMPLAINT REGARDING ONE OF THE BLACK CORDS SNAPPED WAS CONFIRMED BY FAILURE ANALYSIS. COMMON CAUSES OF A BROKEN BIPOLAR CONDUCTOR WIRE ARE ATTRIBUTED TO DAMAGE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, ONE OF THE BLACK CABLES OF THE FORCE BIPOLAR INSTRUMENT SNAPPED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE WAS IDENTIFIED DURING DECONTAMINATION. THE BLACK CORDS FOR THE ARTICULATION OF THE JAW SNAPPED. THERE WAS NO LOSS OF CAUTERY DUE TO THE BROKEN CABLE. THERE WAS NO SIGN OF THERMAL DAMAGE. THE PROCEDURE WAS COMPLETED USING THE SAME INSTRUMENT. THERE IS O REPORT OF FRAGMENTS FALLING INTO THE PATIENT'S ANATOMY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356490 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10241017 0012 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES