BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1931080 · Received November 11, 2010

    Report

    Report Number
    2242352-2010-03288
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE BLOODY. THE SIDE OF THE COLD JAW SILICON BOOT WAS PARTIALLY DETACHED AND PEELING. THE SILICON OF THE COLD JAW INNER CONTACTING SURFACE APPEARED TO BE SOMEWHAT MELTED. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "BOOT PEELED" 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 HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE CLEANING THE JAWS ON THE VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM ACCORDING TO INSTRUCTIONS FOR USE (IFU), THE SILICON INSULATION STARTED TO PEEL. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 25014863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA