BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1881156 · Received October 1, 2010

    Report

    Report Number
    1828100-2010-01598
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 1, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE USER REPORTED THE IMAGE DISPLAYED THROUGH THE ENDOSCOPE WAS BLURRY. THE USER REPORTED THIS SAME EVENT HAS OCCURRED TWELVE TIMES OVER THE PERIOD OF ONE MONTH. THE USER ALSO REPORTED THAT THE ENDOSCOPE HAS BEEN USABLE TO COMPLETE PROCEDURES DESPITE THE DISPLAYED IMAGE BEING BLURRY, BUT THE BLURRINESS IS PROGRESSIVELY GETTING WORSE. 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