BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1954517 · Received January 10, 2011

    Report

    Report Number
    3005992282-2011-00010
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 17, 2010
    Report Date
    November 30, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH THE LOCKING CONNECTOR WAS RETURNED FOR EVALUATION. NOTE THAT THE TUBING STRAIN RELIEF WAS NOT RETURNED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE ACTUATOR RING WAS IN THE LOCKED POSITION, THE HOOKS WERE DEPLOYED, AND THE LOCKING CONNECTOR WAS IN THE LOCKED POSITION. BIOLOGICAL DEBRIS WAS OBSERVED AROUND THE ACTUATOR RING AND HOOKS. MICROSCOPIC EVALUATION, SHOWED PUNCTURES ON THE SEPTUM. DIMENSIONAL ANALYSIS WAS PERFORMED AND THE CONNECTION TUBING ARE MEETING SPECIFICATION. IT IS NOTED THAT THE PRODUCT'S INSTRUCTION FOR USE (IFU) PROVIDES SPECIFIC INSTRUCTIONS REGARDING THE CONNECTION METHOD AND ADEQUATE GRASP METHOD FOR THE PORT POSITIONING AND CONNECTIONS. IT WAS THEREFORE TENTATIVELY CONCLUDED THAT FAILURE MAY HAVE RESULTED IN IMPROPER CONNECTION OF THE TUBING TO THE PORT. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. NO RELEVANT DISCREPANCIES WERE NOTED DURING MANUFACTURING PROCESS. A 100% INSPECTION OCCURS PRIOR TO DEVICE RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER'S SPOUSE THAT POST IMPLANT A REALIZE ADJUSTABLE GASTRIC BAND, THE PORT AND BAND TUBING BECAME DISCONNECTED AND THIS WAS DISCOVERED DURING A BAND FILL UNDER FLUOROSCOPY. A PORT REVISION HAS BEEN SCHEDULED. EXACT DATE UNKNOWN.

    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 ZJHBK8

    Patients

    Seq Age Sex Outcome Treatment
    1