BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE INJECTION PORT AND APP

    MDR report key: 2772286 · Received October 4, 2012

    Report

    Report Number
    3005992282-2012-00133
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    December 5, 2011
    Report Date
    September 7, 2012
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. THE PORT WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT TISSUES WERE PRESENT AROUND HOOK AND ACTUATOR RING OF THE PORT. THE TISSUE IMPEDED THE MECHANISM OF THE INJECTION PORT, AND THEREFORE, IT WAS NOT POSSIBLE TO LOCKED OR UNLOCKED THE ACTUATOR RING. A REVIEW OF THE INSTRUCTION FOR USE (IFU) WAS PERFORMED , AND IT WAS NOTED THAT TISSUES GROWTH MAY IMPEDE ABILITY TO ROTATE THE ACTUATOR RING AND RETRACT THE FASTENING HOOKS, SO THE INJECTION PORT MAY REQUIRE DISSECTION FROM THE FASCIA FOR REMOVAL. ADDITIONAL FUNCTIONAL TESTS WERE PERFORMED AND THE INJECTION PORT WAS FULLY FUNCTIONAL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE SUBASSEMBLY, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INITIAL PROCEDURE ON (B)(4) 2011, WENT WELL. ON (B)(6) 2011, THE PORT WAS REPLACED. THE ACCOUNT STATED THAT THERE WAS A PORT ISSUE, BUT IT IS UNKNOWN HOW THE ISSUE WAS DETECTED OR WHAT THE ISSUE WAS WITH THE PORT. THE PORT WAS REPLACED WITH NO PATIENT CONSEQUENCE. THERE WAS NO ADDITIONAL INFORMATION IN THE NOTES WHEN THE MATERIALS MANAGER CALLED IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE INJECTION PORT AND APP IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZLLBD5

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR