BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1874782 · Received October 19, 2010

    Report

    Report Number
    3005992282-2010-00323
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 27, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH THE LOCKING CONNECTOR WAS RETURNED FOR EVALUATION. PER VISUAL INSPECTION, IT WAS OBSERVED THAT THE ACTUATOR RING WAS IN LOCKED POSITION, HOOKS WERE DEPLOYED. BIOLOGICAL DEBRIS WERE OBSERVED INSIDE OF THE ACTUATOR RING AND HOOKS. PER MICROSCOPIC INSPECTION, IT WAS OBSERVED THAT THE SEPTUM WAS NOT PUNCTURED. DIMENSIONAL MEASUREMENTS WERE PERFORMED ON THE RETURNED COMPONENTS AND ALL VALUES ARE WITHIN SPECIFICATION. THE COMPLAINT CANNOT BE CONFIRMED, PRODUCT'S ANALYSIS CANNOT CONFIRM THE REPORTED EVENT. A REVIEW OF MANUFACTURING RECORDS FOR THE BATCH CONCERNED WAS PERFORMED AND NO RELEVANT DISCREPANCIES WERE NOTED. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. ALL DEVICES ARE INSPECTED PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. PORT REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH LOCKING CONNECTOR WAS RETURNED FOR EVALUATION INSPECTION. THE TUBING STRAIN RELIEF COMPONENT WAS NOT RETURNED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT ACTUATOR RING WAS RETURNED IN LOCKED POSITION, HOOKS WERE DEPLOYED. BIOLOGICAL DEBRIS WAS INSIDE OF HOOKS AND ACTUATOR RING. BY MICROSCOPE IT WAS OBSERVED THAT THE SEPTUM WAS PUNCTURED 7 TIMES. DIMENSIONAL MEASUREMENTS WERE PERFORMED AND WITHIN SPECIFICATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A ROUTINE FILL UNDER FLUOROSCOPY, THE TUBING WAS NOTED TO BE DISCONNECTED FROM THE PORT. THE PROCEDURE TO RE-CONNECT THE TUBING TO THE PORT IS (B)(6) 2010.

    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 ZJNBB7

    Patients

    Seq Age Sex Outcome Treatment
    1