BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSI SPACEMAKER II SURGICAL BALLOON DISSECTOR

    MDR report key: 61297 · Received December 12, 1996

    Report

    Report Number
    1219161-1996-09001
    Event Type
    Malfunction
    Date Received
    December 12, 1996
    Date of Event
    December 3, 1996
    Report Date
    December 3, 1996
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS USED DURING A LAP BURCH PROCEDURE. THE BALLOON BROKE DURING INSERTION. SURGEON DECIDED TO CONVERT TO AN OPEN PROCEDURE. HOSP REPORTED THE PT'S STATUS IS SATISFACTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN