BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19751738 · Received July 16, 2024

    Report

    Report Number
    2955842-2024-17040
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 6, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS USED FOR A SURGICAL TASK AND ONE OF THE WIRES FROM THE INSTRUMENT BECAME EXPOSED. THE CUSTOMER INFORMED THE STAFF TO TAKE AN X-RAY PRIOR TO CLOSURE OF THE INCISIONS TO VERIFY NO FRAGMENTS FELLING INTO THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED. ON 06-MAY-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: "A VESSEL SEALER WAS USED DURING A ROBOTIC SIGMOIDECTOMY AND IT WAS NOTED THAT ONE OF THE WIRES FROM THE INSIDE OF THE INSTRUMENT BECAME EXPOSED. THE VESSEL SEALER WAS TAKEN OFF THE FIELD, AND A NEW ONE WAS OPENED. THE TEAM IS INFORMED TO TAKE AN X-RAY PRIOR TO COMPLETE CLOSURE OF INCISIONS TO VERIFY THERE ARE NO BROKEN PIECES INSIDE THE PATIENT. CHARGE NURSE, DAVINCI REP, AND APSM MADE AWARE. BROKEN PRODUCT: VESSEL SEALER EXTEND". INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523951 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K17240109 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other DA VINCI INSTRUMENTS AND ACCESSORIES.