BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1994388 · Received January 14, 2011

    Report

    Report Number
    2242352-2010-04014
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. 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, THE HEMOPRO JAWS WOULD NOT CAUTERIZE. THE CABLE WAS SWITCHED BUT THE PROBLEM PERSISTED. A REPLACEMENT UNIT AND CABLE WERE USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCTS WERE DISCARDED. IT WAS ALSO REPORTED THAT THE HOSPITAL HAD A HARD TIME KEEPING TRACK OF HOW MAY TIMES THE CABLE WAS STERILIZED SO THEY DISCARDED THE CABLE AS WELL.

    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 25023958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA