BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 3253698 · Received July 24, 2013

    Report

    Report Number
    3253698
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING EXPLORATORY LAP CHOLECYSTECTOMY, HEPATIC LOBECTOMY AND RIGHT PARTIAL HEPATECTOMY, THE SURGEON NOTED THAT THERE WAS A STAPLER MALFUNCTION AND THE STAPLER WOULD NOT OPEN SO THE PROXIMAL ASPECT OF THE LEFT PORTAL VEIN WAS SUTURED BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344376 ENDO GIA STAPLER, SURGICAL GAG COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE * N 2L0393X

    Patients

    Seq Age Sex Outcome Treatment
    1 *