BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2201328 · Received August 3, 2011

    Report

    Report Number
    1124841-2011-00342
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K083194
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED THE ACTUAL DEVICE; UPON EVAL, IT WAS CONFIRMED THAT THE INTERNAL LENS WAS BROKEN, RESULTING IN A CLOUDY VISUAL FIELD. VISUAL INSPECTION NOTED MINOR SCRATCHES, DENTS ON THE ROD AND EYEPIECE OF THE ENDOSCOPE. THIS TYPE OF DAMAGE IS OFTEN ATTRIBUTED TO HANDLING ISSUES. THE DEVICE IFU STATES THAT THE ENDOSCOPE MUST BE HANDLED WITH EXTREME CARE TO PREVENT DAMAGE TO THE DEVICE. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND F/U.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING ENDOSCOPIC VEIN HARVESTING, THE ENDOSCOPE WAS CLOUDY. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK