BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1880341 · Received October 20, 2010

    Report

    Report Number
    2242352-2010-03132
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6) 2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THERE WERE NO NONCONFORMITIES WITH THE DEVICE. THERE WAS NO 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 PRODUCED ENERGY AND STEAM, AND DID NOT REMAIN ACTIVATED. BASED UPON THESE FINDINGS, THE REPORTED FAILURE, "CUTTING BUT NOT SEALING" 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 DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE ABOUT THREE MONTHS PRIOR TO THE DATE OF THIS REPORT, THE VASOVIEW HEMOPRO DEVICE WAS CUTTING BUT NOT SEALING, WHICH LED TO SOME BLEEDING. A NEW KIT WAS USED TO STOP THE BLEEDING WITH NO OTHER PT EFFECTS REPORTED. THE REPORTER STATED THIS EVENT CAME UP IN CONVERSATION WHEN DISCUSSING A DIFFERENT EVENT. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. 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 25010352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other