BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31 CIRCULAR STAPLER

    MDR report key: 3874203 · Received June 11, 2014

    Report

    Report Number
    MW5036600
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING SIGMOID COLECTOMY WHEN THE COVIDIEN CIRCULAR STAPLER MALFUNCTIONED. THE STAPLES WERE COMING OUT IN THEIR ORIGINAL UNFIRED STATE WHILE ALSO CUTTING THE TISSUE WITHOUT THE STAPLE LINE BEING PRESENT. IF THE SURGEON HAD NOT HAD ACCESS TO ANOTHER DEVICE THE PATIENT WOULD HAVE HAD TO HAVE A PERMANENT COLOSTOMY. BECAUSE OF THE MALFUNCTION THE PATIENT DID REQUIRE DOUBLE THE ANESTHESIA TIME WHICH IS A CONCERN IN A PATIENT WHO HAS DEMENTIA, HYPERTENSION, AND SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344482 EEA 31 CIRCULAR STAPLER STAPLER GDW COVIDIEN P3M0313KX

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention