BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18111478 · Received November 10, 2023

    Report

    Report Number
    2955842-2023-20067
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 17, 2023
    Report Date
    October 18, 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
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VSE WAS TRANSFERRED TO ENGINEERING FOR PERFORMANCE OF A GRIP FORCE TEST (GFT). ENGINEERING CONFIRMED THE INITIAL FA FINDINGS AND FOUND THAT THE VSE INSTRUMENT PASSED THE GFT AT DIFFERENT WRIST ORIENTATIONS: STRAIGHT 8.22LBS, PITCH: 7.83LBS, YAW: 8.06 LBS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THIS EVENT OCCURRED ON (B)(6) 2023, HOWEVER, THE SINGLE-USE VESSEL SEALER EXTEND (VSE) INSTRUMENT BEING RETURNED WAS USED ON (B)(6) 2023. FOLLOW-UP ATTEMPTS WERE MADE WITH THE CUSTOMER TO ATTEMPT CLARIFYING THIS, BUT THE CUSTOMER INSISTED THE VSE INSTRUMENT BEING RETURNED WAS THE PRODUCT THAT EXPERIENCED THE REPORTED COMPLICATION ON (B)(6) 2023. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VSE INSTRUMENT; THE REPORTED EVENT WAS NOT CONFIRMED/REPLICATED. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, PASSING THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT CUT AND SEALED WITHOUT ANY ISSUES, THERE WAS NO PROBLEM DETECTED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES. ADDITIONAL TESTING THAT WAS PERFORMED AND THE INSTRUMENT PASSED: THE CERAMIC DOT, THE ELECTRIC CONTINUITY TEST, AND THE KNIFE SLOT: .027. THE VSE VERIFIED AS BEING USED IN THE REPORTED EVENT: LOT NUMBER: K12230720-0039 SHOWED THAT IT WAS INSTALLED AND PASSED HOMING SIX TIMES. THERE WERE 369 CUT COMPLETE EVENTS RECORDED WITH NO ERRORS AND ONE CUT FAILED EVENT WAS RECORDED. THE LOGS SHOW 23 COAGULATION EVENTS WITH NO ERRORS AND 424 SEAL EVENTS, OF WHICH SEVEN HAD HIGH INITIAL STARTING IMPEDANCE ERRORS. THE INSTRUMENT WAS USED FOR ABOUT 3 HOURS. THE LOGS SHOW SOME ERRORS WHICH SEEM UNRELATED TO THE INSUFFICIENT SEALING COMPLAINT. LOGS ARE ATTACHED. THE VSE INSTRUMENT RETURNED AND ANALYZED BY FAILURE ANALYSIS: LOT NUMBER: K17230721-0343 SHOWED THAT IT WAS INSTALLED AND PASSED HOMING 4 TIMES. THERE WERE 93 CUT COMPLETE EVENTS WERE RECORDED WITH NO ERRORS. THE LOGS SHOW TWO COAGULATION EVENTS WITH NO ERRORS. THERE WERE 138 SEAL EVENTS THAT WERE RECORDED, OF WHICH 26 OF THE EVENTS HAD HIGH INITIAL STARTING IMPEDANCE ERRORS. THE LOGS SHOW SOME ERRORS WHICH ARE NOT RELEVANT TO THE CUSTOMER COMPLAINT. THE INSTRUMENT WAS USED FOR ABOUT 42 MINUTES.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY SURGICAL PROCEDURE, THE VESSEL SEAL EXTEND (VSE) WAS NOT SUFFICIENTLY SEALING. SURGEON STATED USING THE VSE INSTRUMENT SUCCESSFULLY WHILE DISSECTING THROUGH THE MESENTERY, BETWEEN THE VESSELS, FOR ABOUT 15 MINUTES. THEN WHEN ATTEMPTING TO SEAL THE VASCULAR PEDICLES (THE INFERIOR MESENTERIC ARTERY (IMA), MIDDLE COLIC AND ILEOCOLIC); AFTER SEALING AND CUTTING, THE VESSELS PROCEEDED TO OPEN UP AND STARTED BLEEDING. THIS HAPPENED 3 ADDITIONAL TIMES AFTER THE INITIAL OCCURRENCE, LEADING TO ADDITIONAL BLOOD LOSS. SURGEON STATED NO ERRORS WERE OBSERVED, AUDIBLE TONES WERE HEARD APPROPRIATELY, THE JAWS WERE NOT IMMERSED IN ANY LIQUID AND DID NOT COME INTO CONTACT WITH ANY METAL OBJECTS. THE SURGEON THEN USED THE FENESTRATED BIPOLAR FORCEPS (FBF) AND A SUTURE LIGATION TO RESOLVE THE BLEEDING. THE PATIENT WAS ADMINISTERED 1 UNIT OF RED BLOOD CELLS (RBC) PRIOR TO THE COMPLETION OF THE CASE ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804129 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K17230721 0343 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES