BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GSI SPACEMAKER DISPOSABLE BALLOON DISSECTOR

    MDR report key: 50433 · Received November 7, 1996

    Report

    Report Number
    2951239-1996-00127_2
    Event Type
    Injury
    Date Received
    November 7, 1996
    Date of Event
    October 25, 1996
    Report Date
    October 28, 1996
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE BALLOON DID NOT UNFOLD PROPERLY. WHEN OPENED THE BALLOON INFLATED ONLY ON ONE SIDE AND TORE FASCIA. THE SURGEON CONVERTED TO AN OPEN PROCEDURE. THE HOSP REPORTED THE PT'S STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSI SPACEMAKER DISPOSABLE BALLOON DISSECTOR DISPOSABLE INSTRUMENT GDI GENERAL SURGICAL INNOVATIONS NA G6C12

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention