BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2223175 · Received August 12, 2011

    Report

    Report Number
    1124841-2011-00352
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K0831914
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO RECEIVED THE ACTUAL DEVICE; UPON EVAL, THE COMPLAINT WAS CONFIRMED. DURING THE EVAL, IT WAS ALSO NOTED THAT THE INTERNAL LENS WAS BROKEN. VISUAL INSPECTION REVEALED A LOOSE WHITE RING AND 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).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO ENDOSCOPIC VEIN HARVESTING, DURING SET-UP, THE PLASTIC RING BELOW THE EYE PIECE ON THE ENDOSCOPE CAME OFF. 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 ENDOSCOPIC GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCENDO550R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK