BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 14575780 · Received June 2, 2022

    Report

    Report Number
    2955842-2022-11975
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 3, 2022
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VSE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE OR CONFIRM THE REPORTED EVENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED INITIALIZATION, MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY. THE BLADE WAS INSPECTED WITH NO BLADE OR KNIFE CABLE DAMAGE FOUND. AN ENERGY DELIVERY TEST WAS PERFORMED AND PASSED. A GRIP FORCE TEST WAS ALSO PERFORMED WHILE THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED. REVIEW OF THE LOGS FOUND NO FAILURES RELATED TO THE REPORTED INSTRUMENT. THERE WAS NO PROBLEM DETECTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN ISI FAILURE ANALYSIS ENGINEER (FAE) REVIEWED THE VESSEL SEALER LOGS FOR THIS EVENT. PER THE FAE, VSE INSTRUMENT WAS USED FOR ABOUT 22 MIN DURING THE PROCEDURE AND NO ERRORS WERE VISIBLE IN THE LOGS. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LYMPHADENECTOMY AND RETROPERITONEAL LYMPH NODE DISSECTION PROCEDURE, THE VSE INSTRUMENT DID NOT SUFFICIENTLY SEAL THE LUMBAR ARTERY WHICH LED TO THE SURGEON SUTURING THE DEFECT INTRA-OPERATIVELY. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LYMPHADENECTOMY AND RETROPERITONEAL LYMPH NODE DISSECTION PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT DID NOT SUFFICIENTLY SEAL THE LUMBAR ARTERY WHICH LED TO THE SURGEON SUTURING THE DEFECT INTRA-OPERATIVELY. THE PATIENT REPORTEDLY LOST BLOOD THAT WAS LESS THAT 200ML. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THIS EVENT OCCURRED WHILE THE SURGEON WAS PERFORMING A VESSEL OCCLUSION DURING A RETROPERITONEAL LYMPH NODE DISSECTION (RPLND) PROCEDURE. THE LUMBAR ARTERY WAS 7MM IN DIAMETER OR SMALLER, AND WAS NOT UNDER TENSION. NO TISSUE EFFECT WAS NOTICED DURING THIS SEALING CYCLE. THE SURGEON SAID THEY DID NOT RECEIVE ANY ERRORS DURING THIS EVENT AND THE AUDIBLE CUES WERE NORMAL. THE CONTINUOUS TONE WAS HEARD DURING THE SEALING CYCLE AND THE SEAL COMPLETE TONE WAS HEARD AFTER THE SEALING CYCLE. THE SURGEON SAID THIS TISSUE WAS CUT WITHOUT IT BEING FULLY SEALED DESPITE HAVING RECEIVED THE SEAL COMPLETED TONES. AS A RESULT, THE PATIENT LOST 200ML OF BLOOD; NO TRANSFUSIONS WERE ADMINISTERED. THE SURGEON SAID THIS WAS THE FIRST USE OF THE VSE INSTRUMENT AND IT WAS NOT USED AGAIN AFTER THIS EVENT. THE VSE INSTRUMENT INVOLVED WITH THE ALLEGED INSUFFICIENT SEALING ISSUE WAS REPLACED WITH ANOTHER VSE INSTRUMENT TO CONTINUE THE PROCEDURE. THE SURGEON SAID THEY SUTURED THE LUMBAR ARTERY ON THE AORTA TO RESOLVE THIS BLEEDING. THE SURGEON DID NOT SPECIFY WHAT INSTRUMENTS WERE USED TO CONTROL THE BLEEDING, BUT SAID THE INSTRUMENTS WERE SPECIFICALLY OPENED FOR THIS EVENT. WHEN ASKED HOW THIS EVENT IMPACTED THE PROCEDURE, THE SURGEON SAID IT ¿ADDED TIME AND SOME BLOOD LOSS THAT WAS NOT CLINICALLY SIGNIFICANT.¿ THE SURGEON SAID THIS EVENT DID NOT IMPACT THE PATIENT¿S HEALTH AND THE PATIENT DID NOT HAVE ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT HAS REPORTEDLY RECOVERED AND IS STABLE. THE SURGEON REPORTED THAT THEY BELIEVE THIS EVENT WAS CAUSED BY A ¿VESSEL SEALER ONE OFF FAILURE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439732 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L90211201 0048 10886874115661

    Patients

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