BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2033429 · Received March 24, 2011

    Report

    Report Number
    2242352-2011-00174
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE BURNT. THE DEVICE WAS BLOODY. THE DEVICE WAS TESTED FOR DEACTIVATION AFTER RELEASING THE TOGGLE. THE DEVICE DID NOT ALWAYS FULLY DEACTIVATE WHEN THE TOOL WAS IN THE CANNULA. 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 DISTAL JAW TIPS ASSEMBLY AND HANDLE WERE OPENED UP AND THERE WAS NO NON CONFORMITIES. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "DID NOT SEAL" COULD NOT BE CONFIRMED. HOWEVER, BASED UPON THE OBSERVATION OF THE ACTIVATION NOT RELEASING IN THE CANNULA, THE REPORTED COMPLAINT FOR "TOGGLE 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. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 DID NOT SEAL PROPERLY ONE OF THE BRANCHES IN THE LOWER LEG, CAUSING SOME BLEEDING, APPROXIMATELY 10-15 CC. THIS WAS AFTER ONLY TWO BRANCHES IN THE LOWER LEG, WHICH IS WHERE HE STARTED CUTTING BRANCHES. STANDARD CAUTERY AND THE USE OF CLIPS WAS USED TO BRING THE BLEEDING UNDER CONTROL. THE LOWER LEG WAS OPENED TO OBTAIN THE VEIN. WHEN THE HARVESTER WENT TO THE UPPER LEG ENDOSCOPICALLY, THE TOGGLE DID NOT ALWAYS RELEASE. SOMETIMES IT WOULD RELEASE ITSELF AFTER A FEW BEEPS, AND SOMETIMES THE USER WOULD HAVE TO PUSH THE TOGGLE FORWARD TO TURN OFF THE ENERGY. THE REPORTED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 25028331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other