BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23204668 · Received October 2, 2025

    Report

    Report Number
    2955842-2025-40238
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 11, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ARCING WAS OBSERVED. A VIO3 GENERATOR WAS BEING USED, WITH THE SETTINGS OF CUT: 4 AND COAG: 7. THE INSTRUMENT TIPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE, NOR DID THEY TOUCH ANY STAPLES, CLIPS, OR SUTURES WHILE ENERGIZED. THE JAWS WERE PROBABLY IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE TO THE YAW PULLEY. THE YAW PULLEY WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING OF BOTH BIPOLAR YAW PULLEYS, IN THE SPACE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE COMPLAINT REGARDING ARCING WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING (PRE-ANESTHESIA) A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BURNED ANYWHERE THE SURGEON DIDN'T WANT TO GRILL. WHEN ENERGIZED, A PLACE DIFFERENT FROM THE TIP DISCHARGED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312311 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-19 K10240919 0314

    Patients

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