BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM ACCESS PORT I

    MDR report key: 1150892 · Received September 2, 2008

    Report

    Report Number
    2024601-2008-00532
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 7, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. DEVICE ANALYSIS REVEALS LEAKAGE TO THE PORT SEPTUM WITH NON PENETRATING NICKS NEXT TO THE PORT SEPTUM. MATERIAL FROM THE PORT SEPTUM WAS ALSO NOTED TO BE PULLED FROM THE SEPTUM. ANALYSIS OF THE DEVICE NOTED DAMAGE FROM A SHARP INSTRUMENT TO THE BAND TUBING (THIS IS THE PORTION OF TUBING LOCATED BETWEEN THE STAINLESS STEEL CONNECTOR AND THE BAND, NOT THE STAINLESS STEEL CONNECTOR AND THE PORT). THIS WAS MOST LIKELY CAUSED BY SURGERY TO REMOVE THE BAND. THERE WAS NO INDICATION OF WEAR RELATED DAMAGE TO THE PORTION OF THE LAP-BAND SYSTEM RETURNED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    REPORTED AS: "A PORT LEAK WITH LEAKAGE AT THE SEAL OF THE PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1250410

    Patients

    Seq Age Sex Outcome Treatment
    1