BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1920677 · Received October 26, 2010

    Report

    Report Number
    2242352-2010-03230
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE VERY BLOODY. THE TIP OF THE COLD JAW SILICON WAS PEELING AND RIPPED AND THE METAL JAW APPEARED TO BE STICKING OUT OF THE BOOT. THE TIP OF THE HOT JAW SILICON WAS RIPPED ALSO AND THE METAL JAW TIP WAS STICKING OUT. THE HEATER WAS BENT AND THE HOOK WAS OUT OF THE JAW AND BOOT SOCKET. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "BOOT PEELED OFF" 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 PT 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