BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2043063 · Received March 15, 2011

    Report

    Report Number
    1124841-2011-00111
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVAL OF THE DEVICE, THE COMPLAINT WAS CONFIRMED. VISUAL INSPECTION REVEALED MINOR DAMAGE TO THE DEVICE AND ITS LENS. THE DAMAGE MAY BE FROM RECURRENT USE AND WEAR OVER TIME FROM STERILIZATION AND HANDLING. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CLINICAL ACTIVITIES, DURING AN INSPECTION OF THE DEVICE, THE ENDOSCOPE WAS BLURRY. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED AT NON-CLINICAL ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM ENDOSCOPE GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCENDO550R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK