BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 1070574 · Received June 27, 2008

    Report

    Report Number
    1070574
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LEVER TO CAUTERIZE GOT STUCK IN AN ON POSITION AND BEGAN TO SMOKE AND GOT EXTREMELY HOT WHILE IN THE PTS RIGHT LEG DURING OPERATION. IT WAS REMOVED BEFORE CAUSING ANY HARM AND REPLACED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVEST KIT GCJ BOSTON SCIENTIFIC CORP * 8040871

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR