BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17695106 · Received September 6, 2023

    Report

    Report Number
    2955842-2023-18254
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT ASSOCIATED WITH THIS COMPLAINT, AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS COMPLETED. FA DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT OF INSUFFICIENT SEALING. THE FA INVESTIGATION WAS INCOMPLETE, DUE TO THE PHYSICAL DAMAGE TO THE INTEGRATED CABLE CORD, WHICH PREVENTED THE NORMAL USE OF THE INSTRUMENT. THE FUNCTIONAL TEST REQUIRED TO ASSESS ENERGY DELIVERY COULD NOT BE PERFORMED. HOWEVER, THE CONTINUITY TEST PASSED, FROM THE BACK-END PIN TO THE GRIP ELECTRODE. THE INSTRUMENT WAS FOUND WITH A DISLODGED BLADE AT THE GARAGE TRACK. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE BLADE WAS EXPOSED OUTSIDE OF THE BLADE GARAGE BY APPROXIMATELY 0.145¿. NO CONDUCTOR WIRE DAMAGE OR SNAKE WRIST DAMAGE WAS FOUND. THERE WAS A LARGE AMOUNT OF BIO DEBRIS FOUND AT THE INSTRUMENT TIP. THE BLADE WAS MANUALLY RESEATED AND PLACED ON THE SYSTEM AGAIN. THE SELF- TEST PASSED DURING IN-HOUSE TESTING. JAW/KNIFE TRACK CONTAMINATION BY RESIDUAL OR CARBONIZED TISSUE CAN PREVENT FULL RETRACTION OF THE BLADE INTO THE INSTRUMENT GRIPS AFTER CUTTING. CUTTING THICK/HARD TISSUE BUNDLES LARGER THAN THE INSTRUMENT'S INDICATIONS MAY ALSO LEAD TO AN EXPOSED BLADE. THE KNIFE SLOT CHECK PASSED AT 0.028", AND THE CERAMIC DOT VERIFICATION PASSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CUSTOMER'S CLAIM AGAINST THE PRODUCT. AN INVESTIGATION IS IN PROGRESS TO DETERMINE, THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PRODUCT FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE ADVANCED INSTRUMENT LOG FOR THE VESSEL SEALER EXTEND INSTRUMENT ASSOCIATED WITH THIS EVENT WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE LOGS SHOW THAT THE INSTRUMENT WAS INSTALLED 4 TIMES, AND IT PASSED HOMING 4 TIMES. A TOTAL OF 6 CUT COMPLETE AND 1 CUT FAILED EVENTS WERE RECORDED. THE LOGS ALSO, SHOW 1 COAG EVENT WITH NO ERRORS AND 60 SEAL EVENTS, OF WHICH 8 HAD HIGH INITIAL STARTING IMPEDANCE ERRORS. THE SYSTEM LOGS SHOWED A FEW ERRORS. WHICH SEEMED, UNRELATED TO THE CUT FAILED ERROR.

    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 MALIGNANT HYSTERECTOMY PROCEDURE. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT FAILED TO SEAL THE UTERINE VESSELS. PER THE SURGEON, THE UTERINE ARTERIES AND VEINS ARE TYPICALLY SEALED AND CUT AT THE SAME TIME, AS THEY RUN NEXT TO ONE ANOTHER. SHE SEALED AND CUT THE VESSELS ON THE RIGHT SIDE OF THE UTERUS, FIRST. SHE HEARD BOTH THE CONTINUOUS AUDIBLE TONES, WHILE THE PEDAL WAS PRESSED, DURING THE SEALING SEQUENCE. AND THE FAST AUDIBLE TONES, INDICATING THAT THE SEAL WAS COMPLETE. SHE ALSO SAW SOME TISSUE EFFECT TO INDICATE CAUTERY, AND THE JAWS WERE COMPLETELY CLOSED. EVERYTHING APPEARED TO BE PROCEEDING NORMALLY. HOWEVER, AFTER THE VSE CUT THROUGH THE VESSELS, THE PATIENT BEGAN TO BLEED. THE SURGEON KNEW FOR SURE THAT THE UTERINE VEIN WAS NOT SEALED. IT SEEMED LIKE THE UTERINE ARTERY MAY HAVE SEALED, BUT SHE WAS NOT SURE. SHE BELIEVES, THAT BOTH VESSELS WERE BLEEDING, BECAUSE OF THE AMOUNT OF BLOOD LOSS. AND BECAUSE BLOOD GOT ON THE CAMERA. THE SURGEON WAS NOT ABLE TO CONTROL THE BLEEDING, AND THE CASE WAS CONVERTED TO OPEN LAPAROTOMY. THE ESTIMATED BLOOD LOSS WAS 900 ML. AND THEY TRANSFUSED TWO UNITS OF BLOOD. THE BLEEDING WAS RESOLVED, WITH THE USE OF SURGICAL CLAMPS AND SUTURE TIES. SHE ALSO ATTEMPTED TO SEAL THE LEFT UTERINE VESSELS TO STOP THE BACK BLEEDING, BUT WHEN SHE REMOVED THE VSE, AFTER THE SEALING SEQUENCE. BOTH VESSELS RE-FILLED WITH BLOOD, AS THOUGH THEY HAD NEVER BEEN SEALED. THE CONTINUOUS AND FAST AUDIBLE SEALING TONES WERE ALSO HEARD FOR THE SEALING SEQUENCE ON THE LEFT SIDE. THE VSE WORKED WELL FOR ABOUT 30 MINUTES PRIOR TO THE ISSUE. THERE WERE NO ERROR MESSAGES AT THE TIME OF THE EVENT. THE INSTRUMENT DID NOT COME INTO CONTACT WITH ANY CLIPS, SUTURES, STAPLES, OR OTHER METAL OBJECTS. AS SHE TYPICALLY DOES NOT USE THEM IN SURGERY. THE JAWS WERE NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE/BIO-DEBRIS PRIOR TO OR DURING THE SEALING CYCLE. SHE DID NOT KNOW WHAT COULD HAVE CAUSED THE ISSUE. AS THE VSE INSTRUMENTS HAVE WORKED WELL FOR HER IN THE PAST. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123316 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K19230525 0164

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.