BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 2221790 · Received August 24, 2011

    Report

    Report Number
    3005992282-2011-00180
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 2, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH THE LOCKING CONNECTOR AND TUBING STRAIN RELIEF WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE ACTUATOR RING WAS RETURNED IN LOCKED POSITION, HOOKS WERE DEPLOYED. LOCKING CONNECTOR WAS IN LOCKED POSITION. BIOLOGICAL DEBRIS WAS OBSERVED AROUND HOOKS AND ACTUATOR RING. UPON MICROSCOPIC EVALUATION, IT WAS NOTED THAT THE INJECTION PORT HAD 25+ PUNCTURES. A CRACK OF 4.7 CM OF LENGTH WAS OBSERVED ON THE TUBING STRAIN RELIEF. A BLOCKAGE AND LEAK TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED AND ALL MET SPECIFICATION. PRODUCT ANALYSIS CANNOT CONFIRM THE REPORTED EVENT. 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 MANUFACTURE OF THE IN BATCH QUESTION. IT IS ALSO NOTED THAT EACH AND EVERY DEVICE IS INSPECTED PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT POST IMPLANT A REALIZE ADJUSTABLE GASTRIC BAND, THE PATIENT DUE TO NO RESTRICTIONS. A FLUOROSCOPY WAS PERFORMED AND IT WAS NOTICED THE TUBING WAS NOT ATTACHED TO THE PORT. THE METALLIC SLEEVE FOR THE TUBING WAS STILL ATTACHED TO THE PORT. THE PORT WAS REPLACED AND A LEAK TEST WAS COMPLETED. PATIENT IS STABLE AND BEING RELEASED HOME.

    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 ZJMBJC

    Patients

    Seq Age Sex Outcome Treatment
    1