BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2971083 · Received February 15, 2013

    Report

    Report Number
    2242352-2013-00183
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MAQUET CARDIOVASCUALR, 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 COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (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 # 2242352-2013-00088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69843 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCUALR, LLC VH-3000 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other