BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2083340 · Received May 10, 2011

    Report

    Report Number
    3005992282-2011-00108
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 15, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH THE LOCKING CONNECTOR WAS RETURNED FOR EVALUATION. THE TUBING STRAIN RELIEF WAS NOT RETURNED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE ACTUATOR RING WAS RETURNED IN LOCKED POSITION, HOOKS WERE DEPLOYED. ONE HOOK WAS BENT (PROBABLY RESULT OF THE EXPLANTATION OF THE INJECTION PORT), BIOLOGICAL DEBRIS WERE OBSERVED INSIDE OF THE ACTUATOR RING. UPON MICROSCOPIC EVALUATION, IT WAS NOTED THAT THE SEPTUM WAS PUNCTURED OVER 40 TIMES. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED AND MET ALL SPECIFICATION. NO OTHERS TESTS THAN OUTLINED ABOVE WERE PERFORMED. THE COMPLAINT CANNOT BE CONFIRMED. DEVICE MET SPECIFICATIONS. THE PRODUCT'S INSTRUCTION FOR USE (IFU) PROVIDES SPECIFIC INSTRUCTIONS REGARDING THE CONNECTION METHOD AND ADEQUATE GRASP METHOD FOR THE PORT POSITIONING AND CONNECTIONS. FAILURE TO CONNECT PER THE IFU, MAY RESULT IN PORT DISCONNECTION. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. NO RELEVANT DISCREPANCIES WERE NOTED DURING MANUFACTURING PROCESS. ALL DEVICES ARE INSPECTED PRIOR TO RELEASE..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE BAND, THE TUBING CAME DISCONNECTED FROM THE INJECTION PORT. THE SURGEON COULD NOT EFFECTIVELY MAKE ADJUSTMENTS. CONTRAST STUDY AND METHYLENE BLUE WERE USED TO DIAGNOSE THE DISCONNECT AND CHECK BAND OR TUBING LEAK. THE PORT WAS REMOVED; TUBING WAS LOCATED IN ABDOMEN AND CONNECTED TO A NEW PORT ATTACHED TO THE FASCIA. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1