BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2013247 · Received March 8, 2011

    Report

    Report Number
    2242352-2011-00132
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HARVESTER MAY HAVE ADVANCED THE VASOVIEW HEMOPRO2 DEVICE INTO TISSUE WHILE THE JAWS WERE OPEN. THIS CAUSED THE CUTTING AND SEALING WIRES TO GET 'MESSED UP' AND COULD NO LONGER BE USED. INSTEAD OF OPENING A NEW KIT, THE HARVESTER DECIDED TO EXTEND THE INCISION A SMALL AMOUNT (ABOUT AN INCH OR LESS) TO FINISH THE LAST BRANCH. THERE WERE NO OTHER PT EFFECTS OR HARM TO THE VEIN. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25024767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other