BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITRUOSAPH PLUS, EVH

    MDR report key: 4360479 · Received December 18, 2014

    Report

    Report Number
    1124841-2014-00202
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    December 9, 2014
    Report Date
    December 9, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INGO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVAL CODE (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING VEIN HARVESTING PROCEDURE THE V KEEPER WAS LOCKED IN THE CLOSED POSITION, IT WOULD NOT OPEN OR CLOSE. THE LEG HAD TO BE OPENED TO REMOVE THE DEVICE AND TO RETRIEVE THE VEIN. THERE WAS A BLOOD LOSS OF 40CC. THE DEVICE WAS NO LONGER USED AFTER THE EVENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832831 VITRUOSAPH PLUS, EVH LAPAROSCOPEM GENERAL GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. VSP550 31K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other