BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 1883581 · Received September 24, 2010

    Report

    Report Number
    1883581
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    July 12, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MAQUET, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ASSISTANT WAS TAKING THE SAPHENOUS VEIN FROM LEFT LEG WHEN THEY NOTICED SMOKE COMING OUT FROM THE ENDOSCOPIC SCISSORS.======================HEALTH PROFESSIONAL'S IMPRESSION======================FAULTY HANDPIECE (DISPOSABLE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR