BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 3136711 · Received May 23, 2013

    Report

    Report Number
    MW5030329
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MAQUET
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PIECE OF THE ENDOSCOPIC VEIN HARVEST - EVH - DISPOSABLE DEVICE WAS NOTICED MISSING FROM THE TIP. THE PIECE WAS LATER FOUND IN THE POUCH USED TO KEEP LOOSE INSTRUMENTS ON THE SURGICAL FIELD. REASON FOR USE: EVH FOR VEIN RETRIEVAL FOR CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230224 EVH NONE GEI MAQUET 25067689

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR