BEUDAMED
    FDA Adverse Event Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2112526 · Received April 6, 2011

    Report

    Report Number
    1124841-2011-00157
    Date Received
    April 6, 2011
    Report Date
    March 17, 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS, THAT DURING VEIN HARVESTING, THE ENDOSCOPE WAS BLURRY. THERE WAS NO PT INJURY. THERE WAS A DELAY IN THE CONTINUING OF THE VEIN HARVESTING PROCEDURE. 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 MCENDO550R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK