BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) ACCESS PORT I

    MDR report key: 1241870 · Received November 18, 2008

    Report

    Report Number
    2024601-2008-00911
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 22, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ANALYSIS OF THE DEVICE NOTED DAMAGED FROM A SHARP INSTRUMENT TO THE BAND TUBING. ALSO NOTED WERE NON-PENETRATING NICKS TO THE PORT SEPTUM. THE DAMAGE APPEARS TO BE CAUSED BY A NEEDLE. 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 WAS UNABLE TO DUPLICATE OR CONFIRM THE REPORTED EVENT. THERE IS NO OTHER INFORMATION 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". IN ADDITION, THE LABELING ALSO ADDRESSES THE FOLLOWING POSSIBLE OUTCOME OF ACCESS PORT LEAKAGE: "CAUTION: USE OF AN INAPPROPRIATE NEEDLE MAY CAUSE ACCESS PORT LEAKAGE AND REQUIRE REOPERATION TO REPLACE THE PORT. DO NOT USE STANDARD HYPODERMIC NEEDLES AS THESE MAY CAUSE LEAKS. USE ONLY BIOENTERICS LAP-BAND SYSTEM ACCESS PORT NEEDLES."

    Description of Event or Problem · 1

    REPORTED AS A LEAKING PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) ACCESS PORT I DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1449173

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR