BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSAPH PLUS, EVH

    MDR report key: 4017175 · Received August 11, 2014

    Report

    Report Number
    1124841-2014-00121
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CORP HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO 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 SHAFT OF THE V-CUTTER SNAPPED IN HALF DURING THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO PT. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475886 VIRTUOSAPH PLUS, EVH LAPAROSCOPE, GENERAL GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. VSP550 43K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK