BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1903810 · Received November 20, 2010

    Report

    Report Number
    3005992282-2010-00373
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PUNCTURED. THE BAND/BALLOON WITH 60CM OF CATHETER AND THE ONE-WAY VALVE WERE RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED, UPON VISUAL INSPECTION, IT WAS OBSERVED THAT A PUNCTURE WAS PRESENT ON THE BALLOON. THIS PUNCTURE WAS PROBABLY PERFORMED BY A SHARP INSTRUMENT (A NEEDLE). WHILE IT IS NOT POSSIBLE TO PROVIDE A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT IT IS NOTED THAT FLUID LEAKAGE IS A RECOGNIZED EVENT ASSOCIATED WITH GASTRIC BANDING AND THE REALIZE ADJUSTABLE GASTRIC BAND. ITS CAUSES AND CONSEQUENCES ARE OUTLINED WITHIN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). MANUFACTURING PRACTICES WERE REVIEWED AND IT WAS NOTED THAT ALL DEVICES ARE LEAK TESTED PRIOR TO LOT RELEASE. IT IS THEREFORE CONSIDERED UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BAND PREP FOR A LAPAROSCOPIC GASTRIC BAND PROCEDURE, AIR BUBBLES WERE NOTICED. A NEW BAND WAS PULLED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    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 ZLKBDB

    Patients

    Seq Age Sex Outcome Treatment
    1