BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARESTING SYSTEM

    MDR report key: 1854212 · Received September 3, 2010

    Report

    Report Number
    1828100-2010-01308
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 3, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE USER REPORTED THE IMAGE DISPLAYED THROUGH THE ENDOSCOPE WAS CLOUDY AND THE LENSE WAS CRACKED. 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 A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARESTING SYSTEM ENDOSCOPE GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCENDO550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1