BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1963824 · Received December 22, 2010

    Report

    Report Number
    2242352-2010-03744
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE HEATER WAS LIFTED UP SLIGHTLY AND THE JAWS WERE SOMEWHAT BURNT. ONE OF THE METAL COLD JAW TANGS APPEARED BENT. THE DEVICE HAD MINIMAL 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. THE HANDLE AND DISTAL JAW TIPS ASSEMBLY WERE OPENED UP AND THERE WERE NO NON CONFORMITIES. BASED UPON THESE OBSERVATIONS, THE REPORTED COMPLAINT FOR "STOPPED WORKING" COULD NOT BE REPLICATED OR CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NON-CONFORMANCE 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, DURING THE LIGATION OF BRANCHES, THE VASOVIEW HEMOPRO2 WAS REPORTED TO HAVE "STOPPED WORKING." THE DEVICE DID NOT RETURN TO WORKING MODE AFTER OVER 1 MINUTE OF WAITING. 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 25024105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA