BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 1842747 · Received September 23, 2010

    Report

    Report Number
    3005992282-2010-00283
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    December 4, 2008
    Report Date
    September 17, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HOOK RETRACTION IMPEDED BY BIOLOGICAL DEBRIS. THE VELOCITY PORT WITH THE LOCKING CONNECTOR, 10 CM OF CATHETER, AND THE TUBING STRAIN RELIEF WERE RETURNED FOR ANALYSIS. THE TUBING STRAIN RELIEF WAS OBSERVED FREE FLOATING ALONG THE CATHETER. THE ACTUATOR RING WAS ON THE LOCKED POSITION WITH HOOKS DEPLOYED. BIOLOGICAL DEBRIS WAS OBSERVED IN THE SEPTUM RETAINER AREA, IN THE PORT BODY AND UNDER ONE HOOK. THE LOCKING CONNECTOR AND THE CATHETER WERE CORRECTLY CONNECTED TO THE PORT. FOURTEEN PUNCTURES WERE OBSERVED ON THE SEPTUM. FUNCTIONAL TESTING WERE PERFORMED. THE TUBING STRAIN RELIEF WAS REATTACHED TO THE LOCKING CONNECTOR EASILY. DIMENSIONAL MEASUREMENTS WERE PERFORMED ON THE LOCKING CONNECTOR AND MET ALL DESIGN SPECIFICATIONS. AN APPLIER SAMPLE WAS USED TO RETRACTED HOOKS WITH UNSUCCESSFUL RESULT, DUE TO PRESENCE OF BIOLOGICAL DEBRIS IN THE MECHANISM. THE PORT WAS LEAK TEST AND NO LEAKS FOUND. A DHR REVIEW WAS CONDUCTED AND NO DISCREPANCY WAS OBSERVED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF A SAGB, THE SURGEON BELIEVED THE VELOCITY PORT WAS INEFFECTIVE AND WAS REPLACED ON (B)(6) 2010 AS THE PATIENT WAS NOT LOOSING WEIGHT. THE PORT WAS REPLACED WITHOUT ANY PATIENT CONSEQUENCE.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR