BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1873691 · Received September 21, 2010

    Report

    Report Number
    2242352-2010-02873
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE RETURNED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE GRAY SILICON INSULATION (JAW BOOT) ON THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM DISLODGED FROM ITS PROPER PLACEMENT. IT NEVER FELL OFF. THE PHYSICIAN'S ASSISTANT TRIMMED THE PIECE AND COMPLETED THE CASE USING THIS DEVICE. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 25014150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA