BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I

    MDR report key: 1191896 · Received September 30, 2008

    Report

    Report Number
    2024601-2008-00752
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 2, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 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 THE PORTION OF THE LAP-BAND SYSTEM RETURNED. PERFORMANCE TESTS INDICATE NO LEAKAGE AT THE ACCESS PORT OR ACCESS PORT TUBING. THE LAB AS UNABLE TO DUPLICATE OR CONFIRM THE REPORTED EVENT. THERE IS NO OTHER INFO AVAILABLE AT THIS TIME FROM THE SURGEON TO DETERMINE THE CAUSE OF THE ALLEGED EVENT. 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, "THE PORT WAS NOT HOLDING FLUID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1091076

    Patients

    Seq Age Sex Outcome Treatment
    1 NI