BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3122115 · Received May 16, 2013

    Report

    Report Number
    2242352-2013-00448
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. HOWEVER, IT WAS SUBSEQUENTLY DETERMINED THAT THERE WAS NO DEVICE MALFUNCTION; RATHER, THE USER THOUGHT THAT THERE WERE WIRES ON BOTH SIDES OF THE JAW. THIS DEVICE IS DESIGNED WITH ONLY ONE WIRE. WHEN THE CUSTOMER SAW ONLY ONE WIRE, THEY ASSUMED ONE HAD DISLODGED INSIDE THE PT. THE CUSTOMER WAS MADE AWARE OF THE CONFIGURATION OF THE DEVICE. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE HEMOPRO DEVICE, A PIECE OF THE JAW BROKE OFF THE HEMOPRO AND FELL INTO THE PT'S RIGHT LEG. THEY SEARCHED THE LEG BY OPENING UP THE INCISION AND WERE UNABLE TO LOCATE THE PIECE. AN X-RAY WAS TAKEN AND THE RESULT WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216911 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25074131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA