BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1900021 · Received October 22, 2010

    Report

    Report Number
    2242352-2010-03158
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON 10/08/2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE DEVICE. THERE WAS NO EVIDENCE OF BLOOD. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECIFICATIONS. A PRE-CAUTERY 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 SPECIFICATIONS DURING THE DEVICE ACTIVATION. THE DISTAL JAW TIPS ASSEMBLY WAS OPENED UP AND A SMALL CUT WAS FOUND IN THE SHRINK TUBING ON THE WELDER UNIT WIRE. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "INTERMITTENTLY WORKING" WAS 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 HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM WOULD NOT ACTIVATE WHILE TRYING TO HARVEST THE RADIAL ARTERY. A NEW 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 25014837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA