BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH DISSECTOR

    MDR report key: 3763588 · Received April 3, 2014

    Report

    Report Number
    1124841-2014-00040
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K083194
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING PROCEDURE, AN INSUFFLATION FAILURE OCCURRED. THE OPERATOR HAD TO CONVERT TO AN OPEN INCISION OF THE LEG TO RECOVER THE VEIN. CONVERSION TO OPEN INCISION. THE PRODUCT WAS CHANGED OUT. THE SURGERY, WITH THE USE OF THE MCVS550DJ, WAS NOT COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200915 VIRTUOSAPH DISSECTOR ENDOSCOPIC VEIN HARVESTER GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA 2ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other