BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18508747 · Received January 12, 2024

    Report

    Report Number
    2955842-2024-10086
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 14, 2023
    Report Date
    December 14, 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
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. DURING AN ADVANCED ENERGY LOG REVIEW, SYSTEM LOGS SHOW THE INSTRUMENT WAS USED FOR 30 MINUTES. INSTRUMENT LOGS DO NOT SHOW THIS INSTRUMENT IN THE LIST OF INSTRUMENTS, SO IT IS NOT POSSIBLE TO DETERMINE IF ANY CUT OR SEAL EVENTS WERE RECORDED WITH AN ERBE GENERATOR. THE E100 LOGS FOR THIS INSTRUMENT, HOWEVER, SHOW 1 COAG EVENT WITH NO ERROR AND 74 SEAL EVENTS WITH 4 HIGH INITIAL STARTING IMPEDANCE ERRORS, INDICATING THAT THE USER LIKELY TRIED TO CUT/SEAL TOO MUCH TISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED ABDOMINOPERINEAL RESECTION, THE SEAL FROM THE VESSEL SEALER EXTEND (VSE) ON THE SUPERIOR HEMORRHOIDAL VESSEL CONTINUED TO FAIL. THE SURGEON ISOLATED AND RESEALED IT SEVERAL TIMES, YET IT CONTINUED TO BURST. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE ROBOTICALLY. DURING FOLLOW UP WITH THE SURGEON, IT WAS STATED THAT TISSUE EFFECT WAS NOTED ON THE SURROUNDING TISSUE, BUT THE VESSEL DID NOT SEAL. THE TARGET VESSEL WAS THE SUPERIOR RECTAL (HEMORRHOIDAL) ARTERY, NOT LARGER THAN 7MM, THERE WAS NO TENSION, AND THE AREA HAD NOT BEEN PREVIOUSLY TREATED WITH CHEMOTHERAPY OR RADIATION. THE ESTIMATED BLOOD LOSS DUE TO THE INSUFFICIENT SEAL WAS 100 CC, BUT NO TRANSFUSIONS OR ADDITIONAL INTERVENTION WAS PROVIDED DUE TO THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845715 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L87230914 0019 10886874115661

    Patients

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