BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH PLUS VEIN HARVESTING SYSTEM

    MDR report key: 2021833 · Received February 25, 2011

    Report

    Report Number
    1828100-2011-00403
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 15, 2010
    Report Date
    February 25, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A VEIN HARVESTING PROCEDURE, THE USER REPORTED THAT THERE WAS MORE TUNNEL BREATHING THAN EXPECTED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH PLUS VEIN HARVESTING SYSTEM ENDOSCOPE AND ACCESSORIES GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. VSP550

    Patients

    Seq Age Sex Outcome Treatment
    1