BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2180886 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00811
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE JAWS HAD NO NON CONFORMITIES AND SOME SIGNS OF CLINICAL USAGE. THERE WAS SOME EVIDENCE OF BLOOD. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND CABLE. THE DEVICE PERFORMED ACCORDING TO SPECS DURING THE DEVICE ACTIVATION. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "NO POWER" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 WAS BEING USED ON A RADIAL HARVEST AND STOPPED WORKING. THIS OCCURRED ABOUT 1/4 - 1/2 THROUGH THE PROCEDURE; THE DISSECTION WENT FINE; BUT THEN AFTER SEVERAL BRANCH CUTS, THERE WERE NO BEEPS, OR SMOKE AND THE BRANCHES WERE NOT DIVIDING. THEY CLEANED THE JAWS AND RECONNECTED THE CORD, BUT THE DEVICE STILL WOULD NOT WORK. A REPLACEMENT VASOVIEW 7 BISECTOR 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 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 25035991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA