BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER II SURG. BALLOON DISSECTOR W/CANNULA

    MDR report key: 117591 · Received September 4, 1997

    Report

    Report Number
    1527736-1997-02162
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    August 21, 1997
    Report Date
    September 4, 1997
    Manufacturer
    GENERAL SURGICAL INNOVATION
    Product Code
    GDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SM109 WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED AFTER THE SURGEON INFLATED THE BALLOON WITH SALINE IN THE NORMAL FASHION HE REMOVED SALINE FROM THE BALLOON TO FIND SALINE IN THE SPACE WITH A POOR DISSECTION. THE SURGON THEN NEEDED TO CONVERT TO OPEN AS A RESULT OF A LEAK IN THE BALLOON. 8/25/97 IT WAS REPORTED THE BALLOON DID NOT RUPTURE INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER II SURG. BALLOON DISSECTOR W/CANNULA DISSECTOR GDI GENERAL SURGICAL INNOVATION NA 061041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention