BEUDAMED
    FDA Adverse Event Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2013102 · Received March 1, 2011

    Report

    Report Number
    1124841-2011-00085
    Date Received
    March 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT REC'D THE ACTUAL DEVICE FOR INVESTIGATION; HOWEVER, TERUMO IS STILL INVESTIGATING THIS ISSUE, AND WILL BE SUBMITTING A F/U REPORT WHEN MORE INFORMATION IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO VEIN HARVESTING, OUT OF BOX, THERE WAS A TEAR IN THE OUTER PACKAGING, WHICH LED THE USER FACILITY TO THINK THE DEVICE MAY HAVE BEEN COMPROMISED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM VIRTUOSAPH DISPOSABLE GCJ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION MCVS550 09K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK