BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 22360084 · Received June 30, 2025

    Report

    Report Number
    2955842-2025-27470
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112328
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2024-09-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS RECEIVED AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A BROKEN MONOPOLAR YAW PULLEY AT THE POSTS. BROKEN PIECE(S) WERE RETURNED WITH THE INSTRUMENT. SIZE OF MISSING PIECE(S) ARE APPROXIMATELY 6.52¿ X 6.82¿. THE COMPONENTS SURROUNDING THE BREAK DID NOT EXHIBIT DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE BROKEN YAW PULLEY. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT 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 WIRE DID NOT SHOW DAMAGE. THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND CONFIRMED THE SURGEON WAS ABLE TO REMOVE THE BROKEN INSTRUMENT AND THAT AN X-RAY WOULD BE PERFORMED. NO SITE VISIT WAS CONDUCTED. THE PERMANENT CAUTERY SPATULA INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION.

    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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT (PCS) BROKE INSIDE THE PATIENT'S ABDOMEN INTRAOPERATIVELY. THE METAL TIP OF THE PERMANENT CAUTERY SPATULA INSTRUMENT DETACHED, ONLY THE WIRE HOLDING IT TO THE SPATULA, AND IT WAS MOVED LATERALLY; THUS, IT WAS HARD TO REMOVE FROM THE ROBOTIC 8 MM METAL CANNULA. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT WAS CALLED FOR ASSISTANCE AND THE ISI TECHNICAL SUPPORT ENGINEER ADVISED THAT IT WAS THE SURGEON'S DECISION ON HOW TO REMOVE IT. ISI CLINICAL SERVICE REPRESENTATIVE WAS MADE AWARE AND CAME TO THE SITE AS SOON AS HE COULD TO HELP. NONE OF THE CABLES APPEARED TO BE BROKEN/FRAYED. THE TIP BROKE AND DETACHED FROM THE DEVICE. THE INSTRUMENT INITIALLY WOULD NOT STRAIGHTEN AT ITS ARTICULATION JOINT AND THEN THE WRISTED JOINT SUDDENLY CAME OUT OF THE ARTICULATION ENTIRELY. AFTER DISPLACEMENT, THE TIP FROM THE POINT OF ARTICULATION DOWN RESTED AT A 90-DEGREE ANGLE FROM THE POST OF THE INSTRUMENT, HELD ON ONLY BY WIRES. THEY WERE NOT ABLE TO REALIGN THE JOINT INTRA-CORPORALLY NO MATTER WHAT WAS TRIED. GIVEN THE ACUTE BEND IN THE INSTRUMENT, THEY ENCOUNTERED A LOT OF DIFFICULTY WITH REMOVING THE INSTRUMENT. THE INSTRUMENT WAS FINALLY REMOVED UNDER DIRECT VISUALIZATION AFTER EXTENDING THE PORT SITE AND PULLED THROUGH IN TWO PORTIONS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. AN X-RAY WAS PERFORMED PRIOR TO BRINGING THE PATIENT TO RECOVERY TO CONFIRM ALL FRAGMENTS WERE RETRIEVED. THE PATIENT HAS NOT RETURNED DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849483 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-16 K10240808 0139 00886874112328

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES