BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 17358623 · Received July 20, 2023

    Report

    Report Number
    2955842-2023-17183
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 22, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYNCHROSEAL INSTRUMENT HAS BEEN EVALUATED BY THE FAILURE ANALYSIS ENGINEERING (FAE) TEAM. THE INITIAL FA FINDINGS WERE CONFIRMED. A REVIEW OF THE E100 LOGS SHOWED A QUANTITY OF 95 COAGULATION EVENTS WITH NO ERRORS WITH 26 SEAL EVENTS OF WHICH ONLY TWO HAD HIGH INITIAL STARTING IMPEDANCE ERRORS, AND A QUANTITY OF 358 TRANSECT EVENTS. A QUANTITY OF THREE CUT ELECTRODES SHORTED AND A QUANTITY OF FOUR SEAL ELECTRODES SHORTED ERRORS WERE SEEN.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CUT ELECTRODE AT THE DISTAL END. THE BROKEN PIECE, MEASURING APPROXIMATELY 0.070" X 0.455" IN SIZE, WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS RETURNED WITH THE ENERGY CABLE CUT, SO FUNCTIONAL TESTS WERE UNABLE TO BE PERFORMED. THE SYNCHROSEAL INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION, ENGAGEMENT, AND SELF-CHECK TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, ALL NINE JAW CERAMIC DOTS WERE PRESENT AT THE TIPS. ALSO, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET. THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER AT THE PROXIMAL END. THE TEAR MEASURED APPROXIMATELY 0.191" IN LENGTH AND NO MATERIAL APPEARED TO BE MISSING. BASED ON A LOG REVIEW, THE INSTRUMENT WAS FOUND TO HAVE ONE ENGAGEMENT FAILURE, ERROR CODE 22020, WRIST PITCH AXIS. THE ENGAGEMENT FAILURE WAS NOT REPLICATED DURING IN-HOUSE TESTING. THE COMPLAINT REGARDING THE WHITE PLASTIC PIECE ON THE JAWS WAS STARTING TO FALL OFF THE SYNCHROSEAL INSTRUMENT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, THE SURGICAL TECHNICIAN NOTICED THE WHITE PLASTIC PIECE ON THE JAWS WAS STARTING TO FALL OFF THE SYNCHROSEAL INSTRUMENT. NO FRAGMENTS FELL INTO THE PATIENT. A NEW INSTRUMENT WAS OPENED, AND THE CASE PROCEEDED AS PLANNED. 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 WHITE PLASTIC PIECE WAS NOT COMPLETELY DETACHED FROM THE JAWS OF THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING WAS OBSERVED THAT WAS OUT OF THE ORDINARY. THE SURGEON WAS ABOUT TO USE THE DEVICE ON TISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING USE. THE INSTRUMENT WAS SENT BACK TO ISI FOR EVALUATION. THERE ARE NO PHOTOS AND/OR VIDEOS OF THIS EVENT AVAILABLE FOR ISI REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142337 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L10221002 0161 10886874117306

    Patients

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