BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN

    MDR report key: 112327 · Received August 7, 1997

    Report

    Report Number
    112327
    Event Type
    Injury
    Date Received
    August 7, 1997
    Date of Event
    February 4, 1997
    Report Date
    August 6, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE END OF THE PLASTIC LOCK ON TROCAR SEAL BROKE OFF COMPROMISING THE SEAL AND CAUSING A LEAK OF CO2. IN ORDER TO COMPLETE THE OPERATIVE PROCEDURE, THE LAPAROSCOPIC BIRCH PROCEDURE WAS CONVERTED TO AN OPEN METHOD PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN STRUCTURAL BALLOON TROCAR & INFLATION BULB 10 MM FCY ORIGIN MEDSYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization