BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 10797285 · Received November 5, 2020

    Report

    Report Number
    1219930-2020-04763
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    June 4, 2020
    Report Date
    November 5, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: WEIGHT REGAIN AFTER GASTRIC PLICATION: REOPERATIVE SLEEVE GASTRECTOMY OR ROUX-EN-Y GASTRIC BYPASS?¿ANALYSIS OF 116 CONSECUTIVE CASES. SOURCE: OBESITY SURGERY (2020) 30:3982¿3987. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN FEBRUARY 2010 AND SEPTEMBER 2017, 116 PATIENTS UNDERWENT REVISIONAL SURGERY DUE TO INSUFFICIENT WEIGHT LOSS OR WEIGHT GAIN. 72 PATIENTS HAD LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AND 44 PATIENTS HAD SLEEVE GASTRECTOMY. THE STAPLER WAS USED FOR BOTH REVISIONAL PROCEDURES. POST-OPERATIVE COMPLICATIONS IN THE SLEEVE GASTRECTOMY GROUP INCLUDED: 1 GASTRIC LEAK, 1 HEMOPERITONEUM (RESULTING IN REOPERATION), 1 PERIGASTRIC HEMATOMA, AND 1 INTRAABDOMINAL ABSCESS. MORTALITY WAS NIL IN BOTH GROUPS. THE MEAN LENGTH OF HOSPITAL STAY (LOS) WAS 3.2 DAYS ± 1.6 (RANGE, 2¿8) IN THE RYGB (ROUX-EN-Y GASTRIC BYPASS) GROUP AND 2.9 DAYS ± 2.2 (RANGE, 1¿11) IN THE SG (SLEEVE GASTRECTOMY) GROUP, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255178 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R