BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1962768 · Received January 13, 2011

    Report

    Report Number
    2242352-2010-03987
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE C-RING HAD SPLIT IN HALF. THE OTHER HALF OF THE C-RING AND THE SCOPE WASH TUBING WERE RECEIVED SEPARATE. THE SCOPE WASH TUBING WAS INTACT. THE DEVICE HAD SOME EVIDENCE OF BLOOD. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "C-RING SPLIT" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NON-CONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C-RING BROKE INTO TWO PIECES WHILE ATTEMPTING TO LIGATE VEIN BRANCHES IN THE LOWER LEG OF THE PT. THE HARVESTER WAS ABLE TO GRASP THE PIECE AND REMOVE IT THROUGH THE ORIGINAL INCISION WITH NO OTHER PT EFFECTS REPORTED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25023121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other