BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 1973909 · Received January 31, 2011

    Report

    Report Number
    3005992282-2011-00027
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    October 8, 2010
    Report Date
    January 5, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. THE INJECTION PORT, THE LOCKING CONNECTOR, TUBING STRAIN RELIEF AND THREE PICTURES FROM THE SURGEON WERE RETURNED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE ACTUATOR RING WAS RETURNED IN THE UNLOCKED POSITION WITH SEVERAL BROWN AND RED STAINS OBSERVED AROUND THE ACTUATOR RING AND SEPTUM RETAINER. THE SEPTUM WAS PUNCTURED 16 TIMES. ON THE TUBING STRAIN RELIEF IT WAS OBSERVED TWO SMALL TEARS ON THE BIGGER DIAMETER SIDE THE COMPLAINT WAS CONFIRMED, PER PICTURE THE PICTURES PROVIDED BY THE SURGEON, THE TUBING STRAIN RELIEF WAS FLOATING ON THE CATHETER. PER VISUAL INSPECTION, IT WAS NOTED THAT THE TUBING STRAIN RELIEF WAS TORN ON ONE SIDE. TWO SMALL TEARS WERE OBSERVED ON THE BIGGER DIAMETER FROM THE TUBING STRAIN RELIEF. ONE POSSIBLE SCENARIO IS THAT THESE TEARS WERE PERFORMED DURING THE ADJUSTMENT OF THE BAND. THE BAND IS 100% VISUALLY INSPECTED PRIOR TO DISTRIBUTION. WITH RESPECT TO REPORTED PAIN, PRODUCT ANALYSIS CANNOT CONFIRM REPORT PHYSIOLOGICAL IN NATURE. TO MITIGATE THE STRAIN RELIEF "MIGRATION" FROM THE LOCKING CONNECTOR, A DESIGN ENHANCEMENT HAS BEEN IMPLEMENTED WITH THE APPROVAL OF THE FDA TO GLUE THE STRAIN RELIEF TO THE LOCKING CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SIX MONTHS OF THE BAND BEING INSERTED, THE SURGEON DECIDED TO ACT ON THE LEVEL OF PAIN EXPRESSED BY THE PATIENT OF UNCOMFORTABLE FEELING IN HER STOMACH AT THE PORT SITE. UPON RE ENTRY IN TO THE PATIENT THE SURGEON DISCOVERED THE PORT HAD LOST THE CONNECTION WITH THE METAL INSULTOR AROUND THE TUBING AND THIS WAS STICKING INTO THE PATIENT SIDE. THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZKNBD9

    Patients

    Seq Age Sex Outcome Treatment
    1