BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1900461 · Received October 28, 2010

    Report

    Report Number
    1828100-2010-01887
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 28, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE USER REPORTED THE VEIN KEEPER PIN ON THE HARVESTER WOULD NOT CLOSE. 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 THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM HARVESTER GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP MCVS550

    Patients

    Seq Age Sex Outcome Treatment
    1