BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2061467 · Received March 16, 2011

    Report

    Report Number
    2242352-2011-00138
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE MINIMALLY BURNT. THERE WAS 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 AND HANDLE WERE OPENED UP AND THERE WERE NO NON-CONFORMITIES. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "KEPT SHUTTING OFF" COULD NOT BE 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 VASOVIEW HEMOPRO 2 STARTED SHUTTING OFF SOONER AND SOONER. THE HARVESTER WAS ABOUT 2/3 DONE WITH THE BRANCH TRANSECTION. SOME "DIRTY DISSECTION" AND FASCIOTOMY WAS DONE. THE JAWS WERE CLEANED ONCE. THE USER WAITED THE 15-30 SECONDS AFTER SOME SHUT DOWNS, BUT EVEN THEN, IT STILL WOULD ONLY GO 3-4 SECONDS. A PRE-TEST WAS DONE AND THE POWER SETTING WAS 3. A SECOND KIT WAS OPENED WHEN IT STARTED SHUTTING DOWN MORE, BUT AFTER A FEW MINUTES, THE SAME PROBLEM OCCURRED. 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 25026425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA