BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 1931612 · Received December 1, 2010

    Report

    Report Number
    1931612
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MAQUET, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING ENDOVEIN HARVESTING, THE HEMOPRO HARVESTING TOOL USED TO SEAL AND DIVIDE THE BRANCHES OF THE VEIN REMAINED ACTIVE AFTER SEALING AND DIVIDING A BRANCH OF THE VEIN. THE JAWS OF THE HEMOPRO HARVESTING TOOL CONTINUED TO SMOKE AFTER USE DESPITE HAVING RELEASED THE ACTIVATING BUTTON ON THE TOOL'S HANDLE. THE CORD CONNECTING THE HEMOPRO HARVESTING TOOL TO THE ENERGY SOURCE BOX WAS DISCONNECTED IMMEDIATELY FROM THE CORD OF THE TOOL'S HAND PIECE. THE TOOL WAS IMMEDIATELY REMOVED FROM THE VASOVIEW HARVESTING CANNULA AND FROM THE FIELD. THERE WAS NO INJURY TO THE PATIENT.DEVICE HAD BEEN IN USE FOR APPROXIMATELY 5-10 MINUTES. THE HARVESTER WAS USED ON 2-3 BRANCHES PRIOR TO THE INCIDENT. WE HAVE SEEN THIS ISSUE BEFORE.======================HEALTH PROFESSIONAL'S IMPRESSION======================POTENTIAL FOR HARM TO PT OR OPERATOR OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET, INC * 25021907

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR