BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2153004 · Received June 17, 2011

    Report

    Report Number
    2242352-2011-00639
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE JAWS WERE BURNT. THERE WAS EVIDENCE OF BLOOD. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST, IT DID NOT SELF-ACTIVATE OR REMAIN ACTIVATED WHEN THE TOGGLE WAS RELEASED. BASED UPON THE FUNCTIONAL TEST, THE REPORTED FAILURE "DEVICE SELF ACTIVATED" 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 AFTER A 95 MINUTE ENDOSCOPIC VEIN HARVESTING PROCEDURE WAS COMPLETED, THE VASOVIEW HEMOPRO SELF ACTIVATED WHEN IT WAS PLACED ON THE TABLE. THE PROCEDURE HAD BEEN COMPLETED BUT THE SURGEON NOTICED A BURNING SMELL AND THEN SAW THAT THE HEMOPRO WAS SMOKING. THIS DIDN'T AFFECT THE DRAPES OR THE PT. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25027386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA