BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA 80-3.8 SINGLE USE LOADING UNIT

    MDR report key: 4121769 · Received September 26, 2014

    Report

    Report Number
    2647580-2014-00794
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 19, 2013
    Report Date
    June 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: BEFORE USE ON THE PATIENT, A NURSE OPENED THE PACKAGE AND FOUND A PART ON THE BACK OF THE CARTRIDGE WAS DISENGAGED. NEW CARTRIDGE WAS OPENED FOR PROCEDURE. NO PATIENT HARM. OR TIME NOT EXTENDED. PATIENT AGE, WEIGHT AND GENDER: UNKNOWN. NO INFORMATION ABOUT THE USE OF REINFORCEMENT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601379 GIA 80-3.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC GIA8038L P2J0926X

    Patients

    Seq Age Sex Outcome Treatment
    1