BEUDAMED
    FDA Adverse Event Summary report: N

    ENDO UNIVERSAL

    MDR report key: 2221813 · Received August 16, 2011

    Report

    Report Number
    2221813
    Date Received
    August 16, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 16, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    STAPLER, ENDO 40MM FOR HERNIA REPAIRS. THE TIP BROKE OFF TWO TIMES. NOTICED THAT THE STAPLER PRIOR TO PUTTING IT INTO THE PATIENT WAS BROKEN, REPLACED TWO STAPLERS WITH A NEW STAPLER BEFORE PLACING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO UNIVERSAL STAPLER, HERNIA, SURGICAL GDW COVIDIEN 173054 P1C1312
    2 ENDO UNIVERSAL STAPLER, HERNIA, SURGICAL GDW COVIDIEN 173054 P1C1312

    Patients

    Seq Age Sex Outcome Treatment
    1 *