BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20225120 · Received September 16, 2024

    Report

    Report Number
    2955842-2024-19449
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 19, 2024
    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
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. AN ADVANCE ENERGY LOG REVIEW SHOWS THAT THE VSE INSTRUMENT WAS INSTALLED 5 TIMES AND PASSED HOMING EACH TIME. THERE WERE 104 CUT COMPLETE AND 191 SEAL EVENTS THAT WERE NOTED. THERE WERE 8 JAW ANGLE OPEN EVENTS WERE NOTED, INDICATING THAT THE JAWS WERE OPEN TOO WIDE TO ALLOW CUTTING. THIS COULD LIKELY BE DUE TO EXCESSIVE BIO-DEBRIS BETWEEN JAWS, OR THE USER TRYING TO CUT TOO MUCH TISSUE. THERE WERE NO E100 LOGS THAT WERE FOUND, SINCE AN ERBE GENERATOR WAS USED WITH THIS INSTRUMENT. THE LOGS SHOW SOME ERBE RELATED ERRORS NOT DIRECTLY RELATED TO A VSE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 7 DUE TO INTERNAL BLEEDING. THERE WERE NO INTRAOPERATIVE COMPLICATIONS; HOWEVER, THERE WAS AN OCCURRENCE WHERE TISSUE WAS CUT NEAR THE RIGHT UTERINE ARTERY BUNDLE PRIOR TO A FULL SEAL CYCLE. THE BLEEDING WAS RESOLVED BY USING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT AND THE CASE PROCEEDED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. A WEEK AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH BLEEDING AND AN UNSPECIFIED LAPAROSCOPIC PROCEDURE WAS PERFORMED. THE AMOUNT OF BLEEDING, IF A TRANSFUSION OF BLOOD PRODUCTS WAS REQUIRED, OR HOW THE BLEEDING WAS RESOLVED; ARE ALL UNKNOWN. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS CURRENTLY IN GOOD HEALTH. THE FIRST ASSIST PHYSICIAN STATED THE COMPLICATION COULD BE RELATED TO HOW THE VSE INSTRUMENT WAS USED BY THE SURGEON. THE SURGEON HAD HISTORICALLY USED A THIRD-PARTY LAPAROSCOPIC SEALING DEVICE AND UTILIZED THE VSE IN A SIMILAR METHOD OF SEALING AND CUTTING; BITING BIG CHUNKS OF TISSUE, WITHOUT INSPECTING IF THE TISSUE WAS FULLY SEALED PRIOR TO CUTTING. OR THAT THE COMPLICATION AROSE DUE TO A PREEXISTING AND UNDERLYING REACTIVE HYPERTENSION CONDITION THAT THE PATIENT HAD NOT COMMUNICATED, WHICH COULD HAVE BEEN PREVENTED WITH USE OF MEDICATION. THE HEAD SURGEON WAS CONTACTED AND CONFIRMED THE PATIENT¿S PATHOLOGY, AND FURTHER STATED THE COMPLICATION COULD BE DUE TO SEVERAL FACTORS; BUT BELIEVES THE VSE DID NOT WORK CORRECTLY AND COULD NOT BE EXCLUDED AS A FACTOR. THE SURGEON CONFIRMED THERE WAS NO MALFUNCTION OF THE VSE INSTRUMENT DURING SURGERY; THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES OBSERVED. THERE WERE NO ERRORS WHILE USING THE VSE AND THE DESIRED TISSUE EFFECT WAS OBSERVED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525273 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422 U91220525 0184

    Patients

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