BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1963766 · Received December 22, 2010

    Report

    Report Number
    2242352-2010-03701
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE SOMEWHAT BURNT. THE DEVICE HANDLE WAS VERY BLOODY. RESISTANCE MEASUREMENTS DID NOT PASS 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 DID NOT PERFORM AS EXPECTED DURING THE DEVICE ACTIVATION, IT WOULD NOT POWER UP. THE DISTAL JAW TIPS ASSEMBLY WAS OPENED UP AND IT WAS OBSERVED THAT THE PRIMARY JAW WIRE WAS DETACHED FROM THE WELD. BASED UPON THIS OBSERVATION AND THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "STOPPED WORKING" 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 VESSEL HARVESTING PROCEDURE, WHEN USING THE VASOVIEW HEMOPRO2 A LOT OF SMOKE WAS OBSERVED IN THE TUNNEL, THE SMOKE WAS DENSE AND IT TOOK 5-8 SECONDS TO CLEAR. ALSO, DEVICE STOPPED WORKING ABOUT HALFWAY THROUGH THE PROCEDURE. THEY WAITED A FULL MINUTE, BUT IT STILL WOULD NOT WORK. A VASOVIEW HEMOPRO 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 25024106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA