BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA

    MDR report key: 11321375 · Received February 12, 2021

    Report

    Report Number
    2647580-2021-00549
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    December 24, 2019
    Report Date
    February 12, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523004731
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: SIZE-DEPENDENT DIFFERENCES IN THE PROXIMAL REMNANT STOMACH: HOW MUCH DOES A SMALL REMNANT STOMACH AFTER SUBTOTAL GASTRECTOMY WORK? SURGICAL ENDOSCOPY (2020) 34:5540¿5549. PUBLISHED ONLINE: 16 JANUARY 2020. 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 2006 AND 2012, 73 PATIENTS WHO UNDERWENT LAPAROSCOPIC SUBTOTAL GASTRECTOMY AND 83 PATIENTS WHO UNDERWENT LAPAROSCOPIC DISTAL GASTRECTOMY FOR STOMACH CANCER HAD THE FOLLOWING COMPLICATIONS: ABDOMINAL HEMORRHAGE, ABDOMINAL ABSCESS AND DUODENAL STUMP LEAKAGE MANAGED WITH CATHETER DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220547 EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EEA25 10884523004731

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention