BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1932188 · Received December 14, 2010

    Report

    Report Number
    2242352-2010-03594
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 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
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE DEVICE AND SOME SIGNS OF CLINICAL USAGE. THE DEVICE HAD SOME EVIDENCE OF BLOOD. 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 WAS OPENED UP AND A TEAR AND EVIDENCE OF MELTING WERE FOUND IN THE SHRINK TUBING ON THE WELDER UNIT WIRE. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "FAILED TO ENERGIZE" 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 CLAMP ON THE VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM WAS INOPERABLE, IT FAILED TO ENERGIZE. THEY ATTEMPTED TO DETERMINE WHY OVER THE COURSE OF MANY MINUTES INCLUDING DISCONNECTING THEN RECONNECTING BOTH ENDS OF THE PT CABLE, CYCLING THE GENERATOR, REPLACING THE ADAPTER, AND REPEATED TOGGLING OF THE JAW TOGGLE. THEY ONCE BRIEFLY SAW A FEW SECONDS OF SMOKE FROM THE GAUZE, BUT THAT WAS ONLY BRIEFLY AND NEVER HAPPENED AGAIN WITH THE UNIT. 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 25021574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA