BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2971085 · Received February 15, 2013

    Report

    Report Number
    2242352-2013-00088
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICES ARE 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

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO JAWS FAILED TO HEAT UP AND CAUTERIZE. A SECOND DEVICE WAS USED AND IT WAS REPORTED THAT THE SILICONE JAW BOOT BROKE OFF AND FELL INTO THE PT'S LEG. THE HOSPITAL INDICATED THE PIECE WAS NOT RETRIEVED FROM THE PT AS THEY WERE UNABLE TO LOCATE IT. THE HOSPITAL INTENDS TO RETURN THE PRODUCTS IN QUESTION. REFER TO MFR REPORT # 2242352-2013-00183.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69374 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25066368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other