BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22709070 · Received August 4, 2025

    Report

    Report Number
    2955842-2025-32741
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 15, 2025
    Report Date
    July 15, 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
    IN, 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

    CORRECTION: H8 UPDATED TO INDICATE INITIAL USE OF DEVICE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE CHARRING AND/OR LOCALIZED MELTING ON THE OUTER SURFACE OF ONE BIPOLAR YAW PULLEY AT THE BASE OF THE GRIP. AS A RESULT OF THE DAMAGE, A SECTION OF THE ACTIVE ELECTRODE (GRIP) IS EXPOSED THAT WOULD NOT NORMALLY BE EXPOSED. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. A REVIEW OF THE PROCEDURE LOGS CONFIRMED THERE WAS ANOTHER ENERGY PRODUCING INSTRUMENT IN THE PROCEDURE. THE COMPLAINT REGARDING PLASTIC LOOKS BURNT AT THE WORKING END WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE IS ATTRIBUTED TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS PLASTIC TIP LOOKED BURNED AT THE WORKING END. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE THERMAL DAMAGE WAS DISCOVERED WHILE STERILE PROCESSING. THERE WAS NO INJURY TO THE PATIENT. THE INSTRUMENT HAS BEEN SENT TO ISI FOR REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2449042 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K10250515 0008 00886874119808

    Patients

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