BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO RETRACT II

    MDR report key: 1170327 · Received September 12, 2008

    Report

    Report Number
    1170327
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 5, 2008
    Manufacturer
    UNITED STATES SURGICAL CORP (COVIDIEN)
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS DAVINCI (LAPAROSCOPIC) ROBOTIC SACROCOLPOPEXY. UPON EXPLORATION OF THE ABDOMINAL CAVITY, A 0.25CM X 0.50CM PLASTIC PIECE WAS FOUND. ALL DAVINCI INSTRUMENTS AND PORTS WERE EXAMINED AND FOUND TO BE INTACT. THE LAPAROSCOPIC ENDO RETRACTOR WAS EXAMINED AND SHOWN TO HAVE MISSING A SMALL PLASTIC PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO RETRACT II RETRACTOR, LAPAROSCOPIC GAD UNITED STATES SURGICAL CORP (COVIDIEN) 176647 P8F0517

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES| NO OTHER THERAPIES