BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 1945171 · Received November 18, 2010

    Report

    Report Number
    1945171
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    June 3, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING ENDOVEIN HARVESTING OF THE PATIENT'S LEG, THE TIP OF THE DEVICE BEING USED BROKE APART. TWO PIECES OF THE TIP WERE SEEN INSIDE THE LEG AND WERE EXTRACTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR