BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAB-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    MDR report key: 1060032 · Received June 10, 2008

    Report

    Report Number
    2024601-2008-00319
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. MEDWATCH SENT TO FDA ON: 10/JUN/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 SHELL 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 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 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 A PINHOLE OPENING IN THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAB-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR