BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1991592 · Received February 15, 2011

    Report

    Report Number
    3005992282-2011-00045
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 16, 2011
    Report Date
    January 18, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BUCKLE TAB TORN. THE BAND/BALLOON WITH 60CM OF CATHETER AND THE ONE-WAY VALVE WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BUCKLE TAB WAS RETURNED TORN FROM THE BAND. IT WAS ALSO NOTED THAT THE EXTENDER AND BACK TAB WAS PASSED TOO FAR THROUGH THE BUCKLE, AND THAT THE EXTENDER IS BLOCKED, CANNOT BE REMOVED. THE BAND/ BALLOON WAS CUT IN TWO PARTS, THIS CUT WAS PERFORMED BY THE SURGEON IN ORDER TO RELEASE THE BAND (AS DESCRIBED WITHIN THE EVENT DESCRIPTION). SUTURE WAS ALSO RETURNED CUT ON ONE SIDE, AND BAND EXTENDER WAS TORN. A MICROSCOPIC PICTURE OF THE TAB WAS PERFORMED AND SHOWS THE TEAR ON THE BUCKLE TAB. THE COMPLAINT WAS CONFIRMED, UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BUCKLE TAB WAS RETURNED TORN AND THAT THE EXTENDER AND BACK TAB WAS GONE TOO FAR THROUGH THE BUCKLE. A REVIEW OF PRODUCT'S INSTRUCTION FOR USE (IFU) WAS PERFORMED WITH REGARD ON PLACEMENT AND CLOSING OF THE BAND. AND IT WAS OUTLINED THAT DETAIL INFORMATION ARE PROVIDED WITHIN THE IFU TO PERFORM A CORRECT CLOSING, IT IS STATES: GRASP THE BAND EXTENDER WITH ONE GRASPER AND THE BUCKLE TAB WITH THE OTHER GRASPER. PULL THE BAND EXTENDER THROUGH THE BUCKLE UNTIL THE LOCKING SHELL EMERGES THROUGH THE BUCKLE AND PAST THE BUCKLE TONGUE. ONE POSSIBLE SCENARIO IS THAT EXCESSIVE FORCE WAS PERFORMED AT THIS STAGE AND THAT THE EXTENDER AND BACK TAB WAS GONE TOO FAR THROUGH THE BUCKLE, AND THE BUCKLE TAB WAS TORN AND EXTENDER AND BACK TAB FROM THE BAND WERE STUCK. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE. THEREFORE A MANUFACTURING ISSUE IS UNLIKELY TO HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BAND PROCEDURE WHEN THE SURGEON WAS PULLING THE LOCKING CONNECTOR TAB THROUGH THE BUCKLE HE FELT LIKE IT APPEARED STRETCHED. HE STATED THAT HE HAD PULLED THE TAB TOO FAR AND WHEN TRYING TO ADJUST IT DECIDED TO REMOVE IT AND USE A NEW BAND. THE SURGEON DID NOT FEEL COMFORTABLE LEAVING THE BAND IN THE PATIENT. THE PATIENT WAS RELEASED HOME WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1