BEUDAMED
    FDA Adverse Event Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2222667 · Received July 21, 2011

    Report

    Report Number
    1124841-2011-00326
    Date Received
    July 21, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE FOR EVALUATION. INVESTIGATION INTO PAST COMPLAINTS OF SIMILAR MODE OF FAILURE INDICATED THAT THE EVENT MAY HAVE OCCURRED DUE TO DISLODGEMENT CAUSED BY EXCESSIVE PRESSURE PLACED ON V-KEEPER BUTTON. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING, THE GATE ON THE HARVESTER WOULD NOT CLOSE. THE PRODUCT WAS CHANGED OUT. THERE WAS NO PATIENT INJURY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM VIRTUOSAPH DISPOSABLE GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCVS550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK