BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2982949 · Received February 22, 2013

    Report

    Report Number
    2242352-2013-00243
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICES ARE NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBERS ARE UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, FOUR HEMOPRO 2 DEVICES PRODUCED EXCESSIVE SMOKE DURING CAUTERIZATION. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCTS IN QUESTION. REFER TO MFR # 2242352-2013-00118, 2242352-2013-00242, AND 2242352-2013-00244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77548 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA