BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1931889 · Received November 30, 2010

    Report

    Report Number
    2242352-2010-03454
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WERE NO SIGNS OF USAGE. THE COLD BOOT WAS PEELING ON ALL SIDES. THE DEVICE HAD NO EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "JAW BOOT PEELING" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. 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 VESSEL HARVESTING PROCEDURE, WHEN THE OPERATING ROOM STAFF REMOVED THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM FROM THE PACKAGE, THE SILICON JAW BOOT WAS PEELING OFF THE TIP. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. 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 25020692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA