BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22588183 · Received July 24, 2025

    Report

    Report Number
    2955842-2025-31389
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    June 13, 2025
    Report Date
    June 13, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS; RESULTS ARE PENDING INVESTIGATION. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, H2, H3, ANNEX CODES: G, B, C, D, H11. ADDITIONAL INFORMATION AND DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT ON (B)(6) 2025 FOR FAILURE ANALYSIS (FA). VISUAL INSPECTION REVEALED NO DAMAGE TO THE INSTRUMENT. IT WAS TESTED ON AN IN-HOUSE SYSTEM, WHERE IT PASSED BOTH RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY AND WERE PROPERLY ALIGNED. ENERGY WAS RELEASED AS EXPECTED, WITH NO ABNORMAL REACTION FROM THE OPPOSING INSTRUMENT. THE INSTRUMENT WAS FULLY FUNCTIONAL, AND NO PRODUCT ISSUE WAS IDENTIFIED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERBE ENERGY ACTIVATION HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE LOWER MONOPOLAR PORT ON THE ERBE WHILE USING THE COAG FUNCTION AND ERBE ENERGY ACTIVATION HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE LOWER BIPOLAR PORT ON THE ERBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT DELIVERED ENERGY WHILE MONOPOLAR ENERGY WAS BEING ACTIVATED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. AT THE TIME OF THE EVENT, NO ARCING WAS OBSERVED, AND THE SURGEON CONFIRMED THAT THE CORRECT PEDAL WAS USED TO ACTIVATE THE MONOPOLAR ENERGY. ADDITIONALLY, THE FBF INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS, COME INTO CONTACT WITH STAPLES OR CLIPS, OR HAVE ITS JAWS IMMERSED IN FLUID WHEN ENERGY WAS ACTIVATED. HOWEVER, THE INSTRUMENT'S JAWS WERE GRASPING SMALL INTESTINE TISSUE AT THE TIME, WHICH RESULTED WITH THE TISSUE TURNING WHITE AND SHOWING SIGNS OF THERMAL DENATURATION. THE SEVERITY OF THE INJURY, AS WELL AS WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED, REMAINS UNKNOWN. AN INTUITIVE SURGICAL, INC. TECHNICAL SUPPORT ENGINEER WAS CONSULTED AND ADVISED THE STAFF TO DISCONNECT THE BIPOLAR CABLE IF NECESSARY. HOWEVER, IT IS UNKNOWN WHETHER THIS TROUBLESHOOTING STEP SUCCESSFULLY RESOLVED THE UNINTENDED ENERGY ACTIVATION ISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188150 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121 N/A

    Patients

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