BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3011033 · Received March 11, 2013

    Report

    Report Number
    2242352-2013-00232
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING-UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED ON (B)(4) 2013, FROM THE HOSPITAL STATING, "DURING AN ENDOSCOPIC VEIN HARVEST OF THE RIGHT LEG, THE INSULATION ON THE JAW OF THE HEMOPRO SEPARATED FROM THE DEVICE. ALL PIECES WERE RECOVERED. NO PT HARM." THE PIECE WAS RETRIEVED THROUGH THE ORIGINAL INCISION. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102624 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC VH-3000 25061516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other