BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE

    MDR report key: 3890043 · Received September 25, 2013

    Report

    Report Number
    3890043
    Event Type
    Malfunction
    Date Received
    September 25, 2013
    Date of Event
    January 14, 2013
    Report Date
    September 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SIGMOID COLECTOMY, END COLOSTOMY AND HARTMANN POUCH. COVIDIEN TA6035S AUTO SUTURE STAPLER MISFIED. THE ORIGINAL STAPLER WAS SAVED. ANOTHER STAPLER WAS OPENED AND IT WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486720 AUTO SUTURE STAPLER, SURGICAL GAG COVIDIEN TA6035S P2K0788X

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR