BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1872364 · Received October 12, 2010

    Report

    Report Number
    2242352-2010-03069
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON SEPTEMBER 24, 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE JAWS WERE VERY BLOODY AND BURNT. 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, "INTERMITTENT 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. (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 WAS WORKING INTERMITTENTLY. IT WAS NOTICED AT THE END OF THE PROCEDURE, SO THE CASE WAS COMPLETED USING THE REPORTED DEVICE. THERE WERE NO PATIENT 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 25017307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA