BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS 25MM, CURVED

    MDR report key: 7733138 · Received July 30, 2018

    Report

    Report Number
    3005075853-2018-11694
    Event Type
    Injury
    Date Received
    July 30, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036003493
    PMA / PMN Number
    K940967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: THREE YEAR RESULT OF LAPAROSCOPIC VERTICAL BANDED GASTROPLASTY. AUTHOR : ERIK NASLUND, JACOB FREEDMAN, JESPER LAGERGREN, DAG STOCKELD, LARS GRANSTROM. CITATION: OBESITY SURGERY, 9, 369-373, 1999. THE STUDY AIMED TO EVALUATE THE RESULTS OF THE LAPAROSCOPIC VERTICAL BANDED GASTROPLASTY (VBG) IN 60 PATIENTS WITH A FOLLOW-UP OF 6-36 MONTHS. BETWEEN JAN 1995 AND FEB 1998, 60 MASSIVE OBESITY PATIENTS (N=10 MALE AND N=50 FEMALE; AGE OF 41.9±1.4 YEARS) LAP VBG WHERE 15 CASES WERE CONVERTED TO OPEN VBG DUE TO LARGE LEFT LOBE OF THE LIVE (N=13), GASTRIC PERFORATION (N=1) AND SPLENIC INJURY (N=1). IN THE LAP VBG, THE UPPER MIDLINE PORT WAS CHANGED TO A 33-MM PORT (LKT 33 ¿ ETHICON) AND THE ECS 25 CIRCULAR STAPLER WAS INTRODUCED AND FIRED WITH A 32F NASOGASTRIC CATHETER PLACED IN THE STOMACH ALONG THE LESSER CURVATURE TO GUIDE THE POSITIONING OF THE STAPLER. THE LEFT WORKING PORT WAS CHANGED TO AN 18-MM PORT (TEC 18 ¿ ETHICON) AND THE 60-MM ETC 460 LINEAR STAPLER WAS INTRODUCED AND PLACED ALONGSIDE THE 32F CATHETER THROUGH THE CIRCULAR HOLE UP TO THE ANGLE OF HIS. TWO PATIENTS IN THE LAP VBG GROUP WERE FOUND TO HAVE STAPLE-LINE DISRUPTION. THE STAPLER USED IN THIS STUDY CONSISTS OF 4 ROWS, AND THE STAPLE-LINE IS NOT DIVIDED. ALSO, THE STAPLE-LINE IS SHORTER (-4 CM), WHICH MAY AFFECT THE RATE OF STAPLE-LINE DISRUPTION. ONE ADDED BENEFIT OF LAP VBG IS THAT REOPERATION WITH A LAPAROSCOPIC TECHNIQUE IS OFTEN POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574252 ENDO ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036003493

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention