BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2122323 · Received June 13, 2011

    Report

    Report Number
    3005992282-2011-00124
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 31, 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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). BIOLOGICAL DEBRIS IMPEDED ACTUATOR MECHANISM. THE INJECTION PORT WITH THE LOCKING CONNECTOR AND TUBING STRAIN RELIEF WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE ACTUATOR RING WAS RETURNED IN THE LOCKED POSITION, HOOKS WERE DEPLOYED. THE LOCKING CONNECTOR WAS IN LOCKED POSITION, AND CORRECTLY ATTACHED. BIOLOGICAL DEBRIS WAS OBSERVED AROUND THE SEPTUM RETAINER AND ACTUATOR RING IMPEDING THE MECHANICAL MECHANISM. UPON MICROSCOPIC EVALUATION, IT WAS OBSERVED THAT THE SEPTUM WAS PUNCTURED 15 TIMES. NO DAMAGE WAS FOUND ON THE TUBING STRAIN RELIEF. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED ALL MEET SPECIFICATION. THE EVENT COULD NOT BE CONFIRMED FOR PORT DISCONNECT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT A REALIZE BAND, THE PATIENT REPORTED NOT FEELING ANY RESTRICTION. A FLUOROSCOPY WAS PERFORMED AND FOUND THE BAND TUBING WAS DISCONNECTED FROM THE INJECTION PORT. THE PORT WAS REPLACED. THE PATIENT IS DOING 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 ZKJBDN

    Patients

    Seq Age Sex Outcome Treatment
    1