BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 3103190 · Received May 9, 2013

    Report

    Report Number
    3005992282-2013-00040
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    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). UPON VISUAL/ FUNCTIONAL EVALUATION, IT WAS NOTED THAT PORT APPLIER WAS RETURNED FULLY FUNCTIONAL.A REVIEW OF THE PRODUCT'S INSTRUCTION FOR USE (IFU) WAS PERFORMED, AND DETAILED INFORMATION IS PROVIDED WITHIN THE IFU TO THE PLACEMENT OF THE PORT. IT WAS ALSO NOTED THAT IF APPROPRIATE FIXATION CANNOT BE ACCOMPLISHED BY THE INTEGRATED FASTENING HOOKS, THE VELOCITY INJECTION PORT CAN BE SECURED IN PLACE WITH SUTURES USING THE THREE HOLES VISIBLE THROUGH THE ACTUATOR RING IN THE PORT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. LOCATION OF DEVICE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BAND PROCEDURE THE PORT APPLIER WOULD ATTACH THE PORT HOOKS TO THE FASCIA. OPENED A REPLACEMENT PORT APPLIER AND CASE WAS COMPLETED. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203282 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZNMBBD

    Patients

    Seq Age Sex Outcome Treatment
    1