BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    MDR report key: 1123805 · Received August 14, 2008

    Report

    Report Number
    2024601-2008-00430
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 14, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P00008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. A LEAK AND FILL TEST INSPECTION REVEALED NO LEAKAGE OR BLOCKAGE TO THE PORT OF THE LAP-BAND SYSTEM. ANALYSIS OF THE DEVICE NOTED AN OPENING ON THE PORT TUBING LOCATED IN BETWEEN THE PORT/INJECTION SITE AND THE STAINLESS STEEL CONNECTOR. THE OPENING ON THE PORT TUBING MAY BE WEAR RELATED AS THERE IS NO CLEAR EVIDENCE OF SURGICAL DAMAGE. THIS OPENING MAY HAVE BEEN THE CAUSE OF THE LEAKAGE. 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). "CAUTION: FAILURE TO CREATE A STABLE, SMOOTH PATH FOR THE ACCESS PORT TUBING, WITHOUT SHARP TURNS OR BENDS, CAN RESULT IN TUBING BREAKS AND LEAKAGE."

    Description of Event or Problem · 1

    REPORTED BY THE DOCTOR AS: "A PORT REPLACEMENT WITH KINKED PORT TUBING AT THE PORT TUBING JUNCTION. THE DOCTOR WAS NOT ABLE TO FILL THE LAP-BAND SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1224214

    Patients

    Seq Age Sex Outcome Treatment
    1