BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS

    MDR report key: 3848061 · Received May 16, 2014

    Report

    Report Number
    1124841-2014-00073
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING VEIN HARVESTING PROCEDURE, THE V-CUTTER TIP BROKE OFF WHILE IN THE PATIENT'S LEG. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293396 VIRTUOSAPH PLUS EVH GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. WSP550 3ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other