BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1944166 · Received January 3, 2011

    Report

    Report Number
    3005992282-2011-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 13, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WITH IN SPECIFICATION THE BAND/BALLOON WITH 49CM OF CATHETER, THE INJECTION PORT, THE LOCKING CONNECTOR AND THE TUBING STRAIN RELIEF WERE RETURNED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BIOLOGICAL DEBRIS WERE INSIDE OF THE INJECTION PORT. ACTUATOR RING WAS NOT LOCKED . THE TUBING CONNECTION WAS BENT AND PORT BODY WAS DAMAGED ON THE LOCKING CONNECTOR SIDE (PROBABLY PERFORMED DURING THE EXPLANTATION OF THE PORT). THREE HOOKS WERE PARTIALLY RETRACTED AND THE FOURTH REMAINED DEPLOYED. PER MICROSCOPIC INSPECTION, IT WAS NOTED THAT THE SEPTUM WAS PUNCTURED 9 TIMES. NO DAMAGE WAS OBSERVED ON THE TUBING STRAIN RELIEF. DIMENSIONAL ANALYSIS OF THE RETURNED COMPONENTS WAS PERFORMED AND ALL MEET SPECIFICATION. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. NO RELEVANT DISCREPANCIES WERE NOTED DURING MANUFACTURE OF THE IN BATCH QUESTION. IT IS ALSO NOTED THAT EACH AND EVERY DEVICE IS INSPECTED PRIOR TO RELEASE.

    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 DURING A BAND CONVERSION TO A GASTRIC BYPASS PROCEDURE, THE BAND TUBE WAS FOUND DISCONNECTED FROM THE ACCESS PORT. THE PATIENT HAD APPROXIMATELY FOUR ADJUSTMENTS. THE PATIENT IS STABLE.

    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 ZKLBC7

    Patients

    Seq Age Sex Outcome Treatment
    1