BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE

    MDR report key: 1843427 · Received September 21, 2010

    Report

    Report Number
    MW5017537
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 21, 2010
    Manufacturer
    COVIDIEN SURGICAL DEVICES
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT "DURING PROCEDURE, WHILE FIRING GIA, THERE WAS A CLICKING SOUND AND WHEN REMOVING THE GIA FROM TROCAR SITE, IT WAS NOTED THAT THE TIP WAS NOT SECURE AND WHEN REMOVING THE RE-LOAD, PIECES OF GIA FELL OUT". NO REPORTED HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDO GIA UNIVERSAL 12MM GDW COVIDIEN SURGICAL DEVICES ENDO GIA UNIVERSAL N9 J0045

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR