BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1982769 · Received January 6, 2011

    Report

    Report Number
    2242352-2010-03827
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 8, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE DEVICE HAD NO NON CONFORMITIES, NO SIGNS OF USAGE, AND NO EVIDENCE OF BLOOD. RESISTANCE MEASUREMENTS WERE FOUND TO BE OUT OF SPECIFICATION. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PASS THE PRE-CAUTERY TEST, IT WOULD NOT PRODUCE STEAM OR HEAT. BASED UPON THIS, THE REPORTED FAILURE "FAILURE TO DELIVER ENERGY" IS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE. "THE BURNING CORD DID NOT WORK." NO INFO IS AVAILABLE REGARDING HOW THE PROCEDURE WAS COMPLETED. 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 SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25022882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA