BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GSI SPACEMAKER SURGICAL BALLOON DISSECTOR

    MDR report key: 97652 · Received June 10, 1997

    Report

    Report Number
    1219161-1997-00676
    Event Type
    Injury
    Date Received
    June 10, 1997
    Date of Event
    June 3, 1997
    Report Date
    June 5, 1997
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE BALLOON COULD NOT BE DEFLATED. THE SURGEON PUNCTURED THE BALLOON TO REMOVE. THE PROCEUDRE WAS CONVERTED TO OPEN TO COMPLETE. THE PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSI SPACEMAKER SURGICAL BALLOON DISSECTOR DISPOSABLE INSTRUMENT GCJ GENERAL SURGICAL INNOVATIONS NA G6C06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention