BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1844986 · Received September 27, 2010

    Report

    Report Number
    3005992282-2010-00288
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    July 23, 2010
    Report Date
    September 7, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LOCKING CONNECTOR WAS RETURNED IN THE LOCKED POSITION, IT WAS NOTED THAT HOOKS WERE RETURNED DEPLOYED AND THE ACTUATOR RING WAS IN THE LOCKED POSITION. BIOLOGICAL DEBRIS WAS OBSERVED INSIDE OF HOOKS, ACTUATOR RING AND CONNECTION HOUSING. OVER 30 PUNCTURES WERE OBSERVED ON THE SEPTUM. A PORT BLOCKAGE AND LEAK TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT. A FUNCTIONAL TEST WAS PERFORMED ON THE INJECTION PORT WITH A SUCCESSFUL RESULT. HOOKS WERE DEPLOYED AND RETRACTED AS DEFINED IN THE INSTRUCTION FOR USE (IFU). DIMENSIONAL MEASUREMENTS WERE PERFORMED ON THE COMPONENTS RETURNED ALL VALUES WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE ADJUSTABLE BAND, THE PATIENT PRESENTED WITH LACK OF RESTRICTION. DURING THE ADJUSTMENT, THERE WAS DIFFICULTY WITHDRAWING FLUID OUT OF THE BAND. THE ADJUSTMENT WAS NOT DONE UNDER FLUOROSCOPY. DURING A DIAGNOSTIC LAPAROSCOPY ON (B)(6), 2010, THE BAND TUBING WAS OBSERVED TO BE DISCONNECTED FROM THE INJECTION PORT. THE LOCKING CONNECTOR WAS ATTACHED TO THE PORT IN THE LOCKED POSITION. THE STRAIN RELEASE WAS MISSING. THE PORT WAS REPLACED. THE PATIENT IS FINE.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1