BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL

    MDR report key: 1920049 · Received November 24, 2010

    Report

    Report Number
    1920049
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    5MM RUBBER WASHER SEPARATED FROM A TROCAR AND LANDED IN PATIENT'S ABDOMINAL CAVITY. ITEM WAS FORTUNATELY AND PROMPTLY NOTED WITH USE OF CAMERA SCOPE AND REMOVED WITH USE OF GRASPER FROM PATIENT WITHOUT ADVERSE OUTCOME TO THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE CAUSED A FOREIGN BODY THAT IF NOT SEEN COULD HAVE BEEN LEFT IN THE PATIENT CAUSING INFECTION, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL 5MM TROCAR GCJ ETHICON ENDO SURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR NO OTHER THERAPIES