BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 2346872 · Received November 17, 2011

    Report

    Report Number
    MW5023182
    Event Type
    Injury
    Date Received
    November 17, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 17, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON DESCRIPTION: ENDOSCOPIC CLOSURE COLOSTOMY, HERNIORRHAPHY VENTRAL. BOOKWALTER RETRACTOR WAS PLACED FOR EXPOSURE. THE ANASTOMOSIS HAD COMPLETELY FALLEN APART AS IF NO STAPLES HAD BEEN FIRED. PT WAS CONVERTED TO AN OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ENDOSCOPIC CARVED INTRALUMINAL STAPLER GDW ETHICON ENDO-SURGERY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization