BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND STR

    MDR report key: 1869570 · Received October 14, 2010

    Report

    Report Number
    3005992282-2010-00314
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 23, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STRAIN RELIEF CRACKED/BIOLOGICAL DEBRIS IMPEDED PORT FUNCTION. THE INJECTION PORT WITH LOCKING CONNECTOR AND TUBING STRAIN RELIEF WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT HOOKS AND ACTUATOR RING WERE COVERED IN BIOLOGICAL DEBRIS. HOOKS WERE RETRACTED AND THE ACTUATOR WAS ON THE LOCKED POSITION. THE LOCKING CONNECTOR WAS ALSO ON LOCKED POSITION WITH BIOLOGICAL DEBRIS BLOCKING THE LOCKING CONNECTOR IN PLACE. THE SEPTUM WAS PUNCTURED 7 TIMES. IT WAS ALSO OBSERVED THAT SEVERAL CRACKS WERE OBSERVED ON THE TUBING STRAIN RELIEF. ALL CRACKS WERE FOUND ON THE LOCKING CONNECTOR SIDE. NOTE: NO TUBING WAS RETURNED FOR EVALUATION. A CATHETER SAMPLE WAS ATTACHED TO THE SEPTUM RETAINER WITH SUCCESSFUL RESULT. A MECHANICAL TEST COULD NOT BE PERFORMED ON THE PORT (HOOKS RETRACTION AND DEPLOYMENT) DUE TO PRESENCE OF A LOT OF FAT TISSUES. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED AND MEET SPECIFICATION. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND NO RELEVANT DISCREPANCIES WERE NOTED DURING MANUFACTURE OF THE IN BATCH QUESTION. ALL DEVICES ARE INSPECTED PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REALIZE BAND PATIENT PRESENTED TO SURGEON'S OFFICE WITH INTERMITTENT ABDOMINAL PAIN. DURING A LAPAROSCOPY DIAGNOSTIC PROCEDURE ON (B)(6) 2010, IT WAS DISCOVERED THAT THE PORT HAD DISCONNECTED FROM THE BAND TUBING. THE PORT WAS REPLACED. THE PATIENT HAS BEEN VERY SUCCESSFUL WITH THE PROGRAM (100 LBS EWL TO DATE).

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1