BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO UNIVERSAL

    MDR report key: 2953989 · Received January 10, 2013

    Report

    Report Number
    2953989
    Date Received
    January 10, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GCJ
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ENDOSTAPLER WOULD NOT FUNCTION AT ALL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BILATERAL LAPAROSCOPIC INGUINAL HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14117 ENDO UNIVERSAL STAPLER, SURGICAL GCJ COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE 65 4.0 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR