BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL BALLOON COVER

    MDR report key: 152731 · Received February 16, 1998

    Report

    Report Number
    152731
    Event Type
    Injury
    Date Received
    February 16, 1998
    Date of Event
    October 22, 1997
    Report Date
    December 29, 1997
    Manufacturer
    GENERAL SURGICAL INNOVATIONS, INC.
    Product Code
    GDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A LAPAROSCOPIC HERNIA REPAIR. AFTER 4-5 PUMPS OF THE INSUFFLATING BULB, THE BALLOON SUDDENLY LOST PRESSURE AND FAILED TO DEPLOY. THE BALLOON DISSECTOR WAS WITHDRAWN FROM THE ABDOMEN. THE PHYSICIAN NOTED THAT THE BALLOON WAS LEAKING AIR. A TROCAR AND LAPAROSCOPE WERE INSERTED AND IT WAS NOTED THAT THE PERITONEUM HAD RUPTURED WITH A LARGE MIDLINE STRIP HANGING LOOSE IN THE ABDOMEN. A PERITONEAL REPAIR WAS DONE WITHOUT FURTHER INCIDENT. MFR REPRESENTATIVE PRESENT DURING INCIDENT. IMMEDIATE FOLLOW-UP DONE. THE BALLOON WAS RETURNED TO THE MFR. AWAITING FOR FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRAL BALLOON COVER BALLOON COVER GDI GENERAL SURGICAL INNOVATIONS, INC. * G6G07

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention