BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2110907 · Received February 15, 2011

    Report

    Report Number
    2242352-2011-00134
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. (B)(4).

    Description of Event or Problem · 1

    RECEIVED A MEDWATCH USER FACILITY REPORT (B)(4) ON (B)(6) 2011. THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, "THE VASOVIEW HEMOPRO DEVICE, SPECIFICALLY THE VEIN GRASPER, HEATED TO THE POINT OF MELTING THE PLASTIC AT THE END OF DEVICE. DEVICE WAS PLACED ON A PLASTIC TROUGH OF THE DRAPE WHILE WAITING TO BE USED. DEVICE WAS ATTACHED TO THE POWER SUPPLY AT THAT TIME WITH ALL APPROPRIATE POWER CORDS. DEVICE ALARMED, STAFF RESPONDED AND BEGAN TO SMELL BURNING. SOURCE OF SMELL WAS TRACED TO THIS DEVICE AND REMOVED FROM FIELD WITH NO INJURY TO STAFF OR PT. DEVICE POWER SWITCH WAS RECALLED TO HAVE BEEN LEFT IN THE "OFF" POSITION. DEVICE SEQUESTERED. EXTERNAL POWER SOURCE TO BE CHECKED. OTHER DEVICES OF SAME LOT NUMBER PULLED FROM STOCK AS A PRECAUTION." PRODUCT STATUS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25026692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA