BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1041318 · Received May 9, 2008

    Report

    Report Number
    2024601-2008-00245
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 3, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. ANALYSIS OF THE DEVICE NOTED DAMAGE FROM A SHARP INSTRUMENT, CONSISTENT WITH SURGICAL DAMAGE, 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). THERE WAS NO INDICATION OF WEAR RELATED DAMAGE TO THIS PORTION OF THE LAP-BAND SYSTEM RETURNED. PERFORMANCE TESTS INDICATE LEAKAGE FROM THE BOTTOM OF THE ACCESS PORT. THIS BREAKAGE MAY HAVE BEEN THE CAUSE OF THE LEAK. 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: "PORT LEAKING FROM BASE. SLOW LEAK. REMOVED AND REPLACED WITH NEW PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1243020

    Patients

    Seq Age Sex Outcome Treatment
    1