BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1880389 · Received October 15, 2010

    Report

    Report Number
    1828100-2010-01783
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 15, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE, THE USER REPORTED THE IMAGE DISPLAYED THROUGH THE ENDOSCOPE LENS WAS BLURRY. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1