BEUDAMED
    FDA Adverse Event Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 3250779 · Received July 23, 2013

    Report

    Report Number
    3250779
    Date Received
    July 23, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 23, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER ENGAGING THE DC CAUTERY WHILE IN THE LEG DURING AN ENDOSCOPIC SAPHENOUS VEIN HARVEST THE ENERGY DID NOT DISSENGAGE. THE AUDIBLE TONE FROM THE POWER SOURCE CONTINUED WHEN THE BUTTON WAS RELEASED AND THE HEATING ELEMENT ON THE BISECTOR TIP BEGAN TO GLOW "RED HOT." THE BISECTOR WAS QUICKLY WITHDRAWN INTO THE HARVESTING CANNULA AND THE POWER CORD WAS DISCONNECTED. THERE WAS NO INJURY TO THE PATIENT. A NEW VASOVIEW HEMOPRO DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITHOUT INCIDENT.THIS IS THE SECOND TIME THIS ISSUE HAS OCCURRED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ENDOSCOPIC SAPHENOUS VEIN HARVEST FOR CORONARY ARTERY BYPASS PROCEDURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343220 VASOVIEW HEMOPRO ELECTROSURGICAL, VESSEL HARVESTING, GENERATOR GEI MAQUET CARDIOVASCULAR LLC VH-3010 *
    343221 VASOVIEW HEMOPRO ELECTROSURGICAL, VESSEL HARVESTING, INSTRUMENT GEI MAQUET CARDIOVASCULAR LLC * 250790

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR