BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1935868 · Received December 3, 2010

    Report

    Report Number
    2242352-2010-03379
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE COLD JAW SILICON WAS PEELING ON THE SIDES. THERE WAS NO BLOOD AND NO SIGNS OF USAGE. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "FOAM/TIP UNATTACHED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SCISSOR TIP ON THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM WAS BROKEN AND THE FOAM WAS UNATTACHED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    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 25017869

    Patients

    Seq Age Sex Outcome Treatment
    1 NA