BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCULAR STAPLER 25MM

    MDR report key: 3913654 · Received June 30, 2014

    Report

    Report Number
    MW5037052
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ETHICON ENDOSURGY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CURVED ILS STAPLER MISFIRED AND THE ANVIL WAS STUCK PROXIMALLY IN THE LARGE COLON ABOVE THE ANASTOMOSIS. ADDITIONAL OPEN EXPLORATION OF ABDOMINAL CAVITY FOR RETAINED ANVIL WAS NECESSARY. INSTRUMENT SAVED FOR ADDITIONAL INSPECTION. MECHANICAL PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378917 CIRCULAR STAPLER 25MM CURVED ILS STAPLER GDW ETHICON ENDOSURGY CDH25A K4DU1N

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention