BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1854183 · Received September 3, 2010

    Report

    Report Number
    1828100-2010-01284
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE USER REPORTED THERE WAS A INADEQUATE AMOUNT OF LIGHT GETTING THROUGH THE ENDOSCOPE, MAKING THE DISPLAYED IMAGE VERY DARK. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM ENDOSCOPE GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP MCENDO550

    Patients

    Seq Age Sex Outcome Treatment
    1