BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1170263 · Received September 10, 2008

    Report

    Report Number
    2024601-2008-00589
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    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. MEDWATCH SENT TO FDA ON: 10/SEP/08. 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 RING AND 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 TEST 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. FURTHER INFORMATION FROM THE REPORTER REGARDING SERIAL NUMBER HAS BEEN REQUESTED. 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 NONFUNCTIONING LAP-BAND (LEAK) WITH AN INCIDENTAL FINDING OF HIATAL HERNIA THAT IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR