BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 1032627 · Received April 21, 2008

    Report

    Report Number
    2024601-2008-00192
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    January 14, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER I. MEDWATCH SENT TO FDA ON 21/APR/08. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER I. ANALYSIS OF THE DEVICE NOTED BREAKAGE OF THE BAND TUBING LOCATED AT THE STAINLESS STEEL CONNECTOR (THIS IS THE PORTION OF TUBING LOCATED BETWEEN THE STAINLESS STEEL CONNECTOR AND THE BAND, NOT BETWEEN THE STAINLESS STEEL CONNECTOR AND THE PORT). THE BREAKAGE OF THE BAND TUBING MAY BE WEAR RELATED AS THERE IS NO CLEAR EVIDENCE OF SURGICAL DAMAGE. THIS BREAKAGE MAY HAVE BEEN THE CAUSE OF THE LEAKAGE. ANOTHER BREAKAGE WAS NOTED IN THE BAND TUBING WHICH APPEARS TO HAVE BEEN CAUSED BY A SHARP INSTRUMENT PROBABLY DUE TO SURGICAL DAMAGE. THIS BREAKAGE MAY HAVE BEEN MADE TO FACILITATE REMOVAL OF THE DEVICE, AND MAY NOT BE THE CAUSE OF THE LEAKAGE. 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 CRACK IN THE TUBING JUST DISTAL TO THE METAL CONNECTOR.

    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 BIOENTERICS CORPORATION NA 584211

    Patients

    Seq Age Sex Outcome Treatment
    1