BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17604659 · Received August 23, 2023

    Report

    Report Number
    2955842-2023-17939
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INABILITY TO FULLY SEAL IS UNKNOWN. THE VSE INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION AND FAILURE ANALYSIS (FA) FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DISLODGED CONDUCTOR WIRE AT THE DISTAL END TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A SEGMENT OF THE CONDUCTOR WIRE STICKING OUT FROM THE DISTAL END. A LOOP OF WIRE IS STICKING OUT SUCH THAT THE WIRE PROTRUDES ABOVE THE OUTER SURFACE OF THE MAIN TUBE. THE WIRE INSULATION WAS NOT DAMAGED, AND THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS RETURNED WITH THE ENERGY CORD CUT, SO THE CUT AND ENERGY DELIVERY TESTS WERE UNABLE TO BE PERFORMED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM WHERE IT PASSED THE RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS AND THE JAWS OPEN AND CLOSED PROPERLY. THE INSTRUMENT PASSED JAW CERAMIC DOT VERIFICATION AND CERAMIC DOT TESTS AND NO SEALING FAILURES WERE OBSERVED DURING LOG REVIEW. A COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO COMPONENT FAILURE. ADVANCED ENERGY LOGS SHOW THE INSTRUMENT WAS INSTALLED 1 TIME AND PASSED HOMING. 32 CUT COMPLETE EVENTS WERE RECORDED AND 3 JAW ANGLE OPEN EVENTS WERE RECORDED, INDICATING THAT THE VSE JAWS ARE TOO FAR OPEN TO ALLOW CUTTING (AKA SMARTCUT) DUE TO THE LIKELIHOOD OF A BLADE EXPOSURE. THE E-100 GENERATOR LOGS SHOW 1 COAG AND 63 SEAL EVENTS WITH NO ERRORS. THE SYSTEM LOGS DO NOT SHOW ANY ERRORS FOR THE SAME TIMESTAMPS AS THOSE FOR THE JAW ANGLE OPEN ERRORS SEEN IN THE INSTRUMENT LOGS. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT MALFUNCTIONED WITH "NO HARM TO THE PATIENT." THROUGH FOLLOW UP WITH A MATERIALS MANAGEMENT EMPLOYEE AT THE SITE, IT WAS LEARNED THAT THE SURGEON'S OPERATIVE NOTE MENTIONED THERE WAS "BLEEDING NOTED NEAR THE RIGHT UTERINE ARTERY, WHICH WAS CUT AND COAGULATED. THE VESSEL SEALER WAS NOTED TO NOT BE FUNCTIONING AT THIS POINT, AND THE LOOP HAD COME DETACHED. THE VESSEL SEALER WAS REMOVED AND IT WAS NOT REQUIRED TO USE THIS VESSEL SEALER ANY FURTHER. PELVIC IRRIGATION WAS DONE." HOWEVER, SUBSEQUENT FOLLOW UP WITH THE ROBOTICS COORDINATOR REVEALS THE SURGEON MENTIONED INSUFFICIENT SEAL AS THE CAUSE OF THE BLEEDING IN THE OPERATIVE NOTE. ADDITIONAL FOLLOW UP WITH THE SURGEON DID NOT CLARIFY HOW THE BLEEDING BEGAN, HOW MUCH BLOOD WAS LOST OR WHAT WAS DONE AS A RESULT, BUT IT WAS CONFIRMED THAT THE VSE INSTRUMENT CABLE LOOKED TO BE EXPOSED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482808 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K11230414 0201 10886874115661

    Patients

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