BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    MDR report key: 1032869 · Received April 22, 2008

    Report

    Report Number
    2024601-2008-00207
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 27, 2008
    Manufacturer
    COSTA RICA
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGEN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF A DAMAGED DEVICE AS FOLLOWS: "CAUTION: THE BAND, ACCESS PORT AND CALIBRATION TUBE MAY BE DAMAGED BY SHARP OBJECTS AND MANIPULATION WITH INSTRUMENTS. A DAMAGED DEVICE MUST NOT BE IMPLANTED. FOR THIS REASON, A STAND-BY DEVICE SHOULD BE AVAIL AT THE TIME OF SURGERY."

    Description of Event or Problem · 1

    REPORTED AS: "THIS TIME CATHETER BROKE ON THE SIDE OF THE LAPHAND. AS SURGEON WAS ABOUT TO CLOSE IT, THE TUBULE BROKE." F/U: "AS SURGEON WAS ABOUT TO CLOSE THE LAPHAND, THE TUBULE, WHICH IS PART OF IT, BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL) DEVICE FOR TREATMENT OF MORBID OBESITY LTI COSTA RICA NA 1521598

    Patients

    Seq Age Sex Outcome Treatment
    1 NI