BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 1961570 · Received January 14, 2011

    Report

    Report Number
    3005992282-2011-00012
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 30, 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). EXTENSIVE DAMAGE. THE BAND/BALLOON WITH 46.5CM OF CATHETER WAS RETURNED FOR ANALYSIS. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BALLOON WAS DAMAGED ON ONE SIDE. THIS DAMAGE SEEMS TO BE A CUT, THIS CUT IS 4.5CM IN LENGTH, AND LOCALIZED AT 1CM FROM THE CATHETER CONNECTION. IT WAS ALSO NOTED THAT BUCKLE WAS CUT ON ONE SIDE (PROBABLY PERFORMED DURING THE EXPLANTATION). IT WAS ALSO NOTED THAT THREE (3) FOLD LINES WERE OBSERVED ON THE BALLOON LOCALIZED NEAR THE CATHETER CONNECTION. SEVERAL BLUE, BROWN AND BLACK STAINS WERE OBSERVED INSIDE THE BALLOON AND CATHETER. AS RESULT OF THE VISUAL INSPECTION, NO FUNCTIONAL TEST WAS PERFORMED ON THE BALLOON. PER THE VISUAL INSPECTION, THE BALLOON WAS RETURNED WITH EXTENSIVE DAMAGE. THEREFORE, ROOT CAUSE OF THE BALLOON LEAKAGE COULD NOT BE DETERMINED. EXAMINATION OF THE BALLOON SUGGEST THAT DAMAGE OCCURRED ON EXPLANTATION. A DHR REVIEW WAS PERFORMED BY THE COMPLAINT TECHNICIAN NO NON CONFORMANCE WERE FOUND RELEVANT TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE (B)(4) ADJUSTABLE GASTRIC BAND LEAKED POST OP. THE BAND WAS REPLACED WITHOUT ANY REPORTED PATIENT COMPLICATIONS.

    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