BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1203461 · Received October 17, 2008

    Report

    Report Number
    1828100-2008-00512
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    August 5, 2008
    Report Date
    October 17, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR ENDOSCOPIC SAPHENOUS VEIN HARVESTING, THE USER REPORTED THAT THE V-CUTTER WAS NOT ABLE TO CUT AND CAUTERIZE THE VEIN. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1