BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2080995 · Received April 13, 2011

    Report

    Report Number
    2242352-2011-00340
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE BURNT. THERE WAS SOME EVIDENCE OF BLOOD. THE DEVICE WAS TESTED FOR DEACTIVATION AFTER RELEASING THE TOGGLE. THE DEVICE DID NOT FULLY DEACTIVATE WHEN THE TOOL WAS IN THE CANNULA WITH THE SHAFT FLEXED AT AN ANGLE. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECIFICATIONS. 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 SPECIFICATIONS DURING THE DEVICE ACTIVATION. THE HANDLE WAS OPENED UP AND THERE WERE NO NON CONFORMITIES. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "TOGGLE SWITCH STUCK" 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 HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TOGGLE SWITCH OF TWO VASOVIEW HEMOPRO 2 UNITS GOT STUCK IN THE "ON" POSITION AND THEN SHUT OFF. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY 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 25028191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA