BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2061442 · Received March 16, 2011

    Report

    Report Number
    2242352-2011-00139
    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 NON-CONFORMANCE 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