BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS 25MM, CURVED

    MDR report key: 7734634 · Received July 31, 2018

    Report

    Report Number
    3005075853-2018-11707
    Event Type
    Injury
    Date Received
    July 31, 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 # UNKNOWN. AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: FIVE-YEAR RESULTS OF LAPAROSCOPIC VERTICAL BANDED GASTROPLASTY IN THE TREATMENT OF MASSIVE OBESITY. AUTHOR : MÅRTEN MAGNUSSON, MD; JACOB FREEDMAN, MD; EDUARD JONAS,MD; DAG STOCKELD, MD, PHD; LARS GRANSTRÖM, MD, PHD; ERIK NÄSLUND, MD, PHD. CITATION: OBESITY SURGERY. 2002; 12: 826-830. LAPAROSCOPIC SURGERY APPEARS TO OFFER RAPID RECOVERY AND LOW POSTOPERATIVE MORBIDITY. THE AIM OF THE PRESENT STUDY WAS TO ASSESS THE OUTCOME OF LAPAROSCOPIC VERTICAL BANDED GASTROPLASTY (LVBG) IN 154 OBESE PATIENTS WITH A FOLLOW-UP OF 12-60 MONTHS. A TOTAL OF 154 MASSIVELY OBESE PATIENTS (132 FEMALE AND 22 MALE PATIENTS) WITH A MEAN ± SEM BODY MASS INDEX (BMI) OF 43.4 ± 0.6 KG/M2 WERE FOLLOWED PROSPECTIVELY FOR AN AVERAGE OF 31.7±1.4 MONTHS. THIRTY-THREE PATIENTS WERE CONVERTED TO OPEN SURGERY PROCEDURE. DURING THE LVBG PROCEDURE, THE UPPER MIDLINE PORT IS CHANGED TO AN LKT 33 MM PORT (ETHICON) AND THE ECS-25 CIRCULAR STAPLER (ETHICON) IS INTRODUCED AND FIRED WITH A 32-F NASOGASTRIC CATHETER PLACED IN THE STOMACH ALONG THE LESSER CURVATURE TO GUIDE THE POSITIONING OF THE STAPLER. THE LEFT WORKING PORT IS CHANGED TO A TEC 18 OR 15 MM PORT (ETHICON) AND AN ETC-460 LINEAR STAPLER (ETHICON) FOR THE FIRST 82 PATIENTS IS INTRODUCED IN PARALLEL TO THE 32-F CATHETER THROUGH THE CIRCULAR WINDOW UP TO THE ANGLE OF HIS. REPORTED COMPLICATIONS INCLUDED GASTRIC PERFORATION IN THE CIRCULAR WINDOW (N-2) WHICH REQUIRED CONVERSION TO OPEN SURGERY, WOUND INFECTION (N-4), INCISIONAL HERNIA (N-1) WHICH REQUIRED RE-OPERATION, POUCH ENLARGEMENT (N-1) WHICH REQUIRED RE-OPERATION, BLEEDING (N-1) WHICH REQUIRED RE-OPERATION, STAPLE RUPTURE (N-4) WHICH REQUIRED RE-OPERATION OF NEW STAPLE LINE, AND STENOSIS (N-1). IT WAS REPORTED THAT THE LVBG CAN BE PERFORMED SAFELY AS A SURGICAL TREATMENT FOR OBESITY AND OFFERS SAFE WEIGHT LOSS WITH FEW PERI- AND POSTOPERATIVE COMPLICATIONS. WEIGHT LOSS AND VBG-RELATED COMPLICATIONS ARE SIMILAR TO THAT SEEN AFTER OPEN VBG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578943 ENDO ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNKNOWN 20705036003493

    Patients

    Seq Age Sex Outcome Treatment
    1