BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2132512 · Received June 17, 2011

    Report

    Report Number
    3005992282-2011-00141
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT AND LOCKING CONNECTOR WERE RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT INJECTION PORT WAS COVERED WITH BIOLOGICAL DEBRIS. THE ACTUATOR RING WAS IN LOCKED POSITION, AND HOOKS WERE DEPLOYED. ONE HOOK WAS NOTED TO BE BENT. THE LOCKING CONNECTOR WAS IN LOCKED POSITION. UPON MICROSCOPIC EVALUATION IT WAS NOTED THAT THE SEPTUM WAS PUNCTURED 11 TIMES. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WERE PERFORMED PER (B)(4), ALL MET SPECIFICATIONS. NO OTHERS TESTS THAN OUTLINED ABOVE WERE PERFORMED. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED AND MET SPECIFICATIONS. THE COMPLAINT CANNOT BE CONFIRMED; PRODUCT ANALYSIS CONFIRMED THAT DEVICE DIMENSIONS AROUND THE CONNECTION TUBING WERE WITHIN SPECIFICATIONS. IT WAS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT. PORT DISCONNECTION IS A RECOGNIZED EVENT ASSOCIATED WITH GASTRIC BANDING. 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. A POTENTIAL CAUSE OF THE REPORTED EVENT IS THE FAILURE TO PROPERLY CONNECT THE BAND TUBING TO THE INJECTION PORT. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. ALL DEVICES UNDERGO A 100% INSPECTION PRIOR TO RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PORT DISCONNECTION POST IMPLANT A REALIZE BAND. THE PORT WILL BE REVISED. THE PORT WAS REVISED ON (B)(6), 2011. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE.

    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 ZKBBCD

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention