BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1953875 · Received November 24, 2010

    Report

    Report Number
    1828100-2010-02255
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 24, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 HARVESTER WOULD NOT CUT. THE USER IDENTIFIED THE CABLE CONNECTING THE HARVESTER TO THE ELECTROSURGICAL GENERATOR AS THE SOURCE OF THE MALFUNCTION. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE 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 BIPOLAR CORD GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCBICORD1

    Patients

    Seq Age Sex Outcome Treatment
    1