BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3102147 · Received May 1, 2013

    Report

    Report Number
    3102147
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    APTUS ENDOSYSTEMS, INC.
    Product Code
    OTD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE "BLUE LIGHT" WAS ON AND THE USER INSTRUCTIONS STATED "IF THE BLUE LIGHT IS ON, DO NOT USE THIS DEVICE".WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190599 * ENDOVASCULAR SUTURING SYSTEM OTD APTUS ENDOSYSTEMS, INC. SA-5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR