BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 1855009 · Received September 20, 2010

    Report

    Report Number
    1855009
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    January 12, 2010
    Report Date
    September 20, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE DA VINCI DOUBLE FENESTRATED INSTRUMENT WAS REMOVED FROM THE PT (ROBOTIC ASSISTED LAP ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY), THE INSTRUMENT TIP BROKE OFF AND WAS NOT DETECTED BY X-RAY. THE SURGEON OPENED, TISSUE MORCELLATED, NO IDENTIFIABLE PART FOUND IN WOUND OR MORCELLATED TISSUE. THE AREA WAS IRRIGATED WELL AND SEARCHED - NO FOREIGN OBJECTS WERE DETECTED IN THE WOUND AREA.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE INSTRUMENT TIP BROKE OFF OF THE DOUBLE FENESTRATED GRASPER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST GRASPER, FENESTRATED NAY INTUITIVE SURGICAL, INC. 420189 0106071 038

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR