BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2222141 · Received August 24, 2011

    Report

    Report Number
    3005992282-2011-00183
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PUNCTURE THE BAND/BALLOON WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, A HOLE WAS NOTICED IN THE BALLOON, WHICH APPEARED TO HAVE BEEN PERFORMED BY A SHARP INSTRUMENT (I.E. GRASPER). AS RESULT OF THE VISUAL INSPECTION, NO LEAK TEST WAS PERFORMED. A REVIEW OF THE INSTRUCTION FOR USE (IFU) WAS PERFORMED AND DETAILED INSTRUCTIONS WERE OUTLINED WITHIN THE IFU ON HOW TO AVOID ANY DAMAGE TO THE DEVICE DURING IMPLANT. IN ADDITION, THE IFU STATES TO LEAK TESTED WITH 11ML OF AIR AND IMMERSE IN STERILE SALINE BEFORE IMPLANT, TO DETECT FOR A LEAK A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURING PROCESS WAS PERFORMED AND IT IS NOTED THAT ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO RELEASE; THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE OP OF A REALIZE ADJUSTABLE GASTRIC BAND PROCEDURE WHEN ADDING THE SALINE PRIOR TO THE PROCEDURE THERE WAS A LEAK. A PENCIL SIZE HOLE WAS IN THE BAND. THEY USED ANOTHER BAND TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1