BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER II

    MDR report key: 54355 · Received September 30, 1996

    Report

    Report Number
    54355
    Event Type
    Injury
    Date Received
    September 30, 1996
    Date of Event
    June 5, 1996
    Report Date
    June 14, 1996
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 53-YR-OLD MALE UNDERWENT LAPAROSOCPIC BILATERAL INGUINAL HERNIA REPAIR WITH MARLEX MESH. INITIALLY THE SPACEMAKER SURGICAL BALLOON DISSECTOR HAD AN AIR LEAK AND THE BALLOON WOULDN'T INFLATE, SUBSEQUENTLY THE BALLOON INFLATED, SUBSEQUENTLY IT WAS NOTED THAT PT SUSTAINED A PERIOTONEAL TEAR WHICH LENGTHENED THE SURGICAL PROCEDURE AND REQUIRED SURGICAL REPAIR WITH ENDOSTITCHES. THE PHYSICIAN COULDN'T STATE WITH CERTAINTY WHETHER INITIAL FAILURE OF BALLOON TO INFLATE CAUSED THE PT'S PERITONEAL TEAR. PT ADMITTED 23 HRS AND DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER II SURGICAL BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS VSM - 2900 - 01 G6B13

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention