BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2001560 · Received January 26, 2011

    Report

    Report Number
    1828100-2011-00189
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 26, 2011
    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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE USER REPORTED THE TIP ON THE DISECTOR WAS FULL OF MOISTURE WHICH OBSTRUCTED THE VIEW ON THE MONITOR. AS A RESULT, AN ALTERNATE HARVESTER WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    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