BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1882739 · Received October 13, 2010

    Report

    Report Number
    2242352-2010-03078
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6), 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THERE WERE NO NON-CONFORMITIES WITH THE JAWS. THERE WAS SOME EVIDENCE OF BLOOD AND TISSUE ON THE HOT JAW AND HANDLE. 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 PRODUCED ENERGY AND STEAM, AND DID NOT REMAIN ACTIVATED. BASED UPON THESE FINDINGS, THE REPORTED FAILURE, "NO POWER" COULD NOT BE CONFIRMED. A DEVICE LOT HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER, AND THERE ARE NO NON-CONFORMITIES WHICH COULD BE ATTRIBUTED TO THE REPORTED FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM WOULD NOT ACTIVATE. 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 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25016810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA