BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE

    MDR report key: 2141616 · Received June 15, 2011

    Report

    Report Number
    2141616
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    LTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD UNDERGONE LAPAROSCOPIC ADJUSTABLE GASTRIC BAND PLACEMENT ALMOST THREE YEARS AGO. THE SURGEON NOTES FROM THE OPERATIVE NOTE THIS MONTH: "RECENTLY, SHE HAS LOST ALL RESTRICTION WITH HER BAND AND IMAGING STUDIES SHOW LEAKING BAND SYSTEM WITH LEAK PROBABLY AT THE PORT. SHE PRESENTS FOR PORT REPLACEMENT." FINDINGS AT SURGERY: THE PORT AND TUBING SYSTEM OR COMPONENTS TO THE ADJUSTABLE GASTRIC BAND SYSTEM ARE INTACT. THERE IS A LEAKING SITE OF THE PROXIMAL TUBING JUST BEYOND THE PORT COUPLING THAT MOST LIKELY REPRESENTS A NEEDLE HOLE. THE TUBING IS CUT BACK TO FRESH TUBING AND A NEW PORT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE GASTRIC LAP BAND LTI ETHICON ENDO SURGERY * RLZB22 ZJKBC2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR