BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7744926 · Received August 2, 2018

    Report

    Report Number
    2210968-2018-74858
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    July 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: SURG ENDOSC (2013) 27:S276; S087. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : LAPAROSCOPIC GREATER CURVATURE PLICATION FOR MORBIDLY OBESE PATIENTS: EARLY EXPERIENCE OF ALEXANDRIA UNIVERSITY". AUTHOR: MOHAMED SHARAAN, MD (PRESENTER), KHALED KATRY, MD, TAMER ABDELBAKI, MS, FACULTY OF MEDICINE, UNIVERSITY OF ALEXANDRIA. CITATION: SURG ENDOSC (2013) 27:S276; S087. THE STUDY AIMED TO ASSESS THE LAPAROSCOPIC GREATER CURVATURE PLICATION OF THE STOMACH AS AN ALTERNATIVE BARIATRIC PROCEDURE FOR MORBIDLY OBESE PATIENT TO LOOSE WEIGHT. A TOTAL OF 52 MORBIDLY OBESE PATIENTS (N=17 MALE AND N=35 FEMALE; MEAN AGE WAS 38 YEARS; MEAN BMI WAS 44.5 [36-49] KG/M2) UNDERWENT BARIATRIC PROCEDURE. THE LAPAROSCOPIC GREATER CURVATURE PLICATION USING TWO LAYERS, FIRST ONE INTERRUPTED ETHIBOND 2/0 AND SECOND ONE CONTINUOUS PROLENE 2/0 STARTING FROM THE FUNDS TILL THE LEVEL OF THE CROW FOOT OF THE STOMACH. POSTOPERATIVELY, THERE WERE 2 CASES OF PERSISTENT POSTOPERATIVE VOMITING DUE TO OBSTRUCTIVE GASTRIC OUTLET CAUSE OF NARROW POUCH. ONE WAS TREATED JUST BY UPPER ENDOSCOPY AND DILATATION AND THE OTHER BY REMOVAL OF SUTURES NEAR THE OUTLET. THERE WAS NO INTRAOPERATIVE COMPLICATION AND NO LEAKAGE OCCURRED. THE LAPAROSCOPIC GREATER CURVATURE PLICATION OF THE STOMACH IS A FEASIBLE AND SAFE PROCEDURE FOR MORBIDLY OBESE PATIENTS WITH LOW MORBIDITY AND REVERSIBLE IN CASE OF OBSTRUCTIVE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586777 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention