BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2161659 · Received June 13, 2011

    Report

    Report Number
    2242352-2010-03275
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    October 13, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION, THEREFORE NO EVAL COULD BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    A HARVESTER COMPLAINED THAT THE VASOVIEW HEMOPRO DISSECTION TIP (BULLET TIP) BECOMES "FOGGED OR STEAMED" DURING INITIAL TISSUE DISSECTION. HE ATTEMPTED ON SEVERAL OCCASIONS TO CLEAN THE TIP WITHOUT SUCCESS. HE OBTAINED A VH-2004 ACCESSORY KIT TO COMPLETE THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY TO THE PT. THE HARVESTERS REPORTED THAT HE DOES NOT USE OR APPLY ANY ANTI-FOG TO THE SCOPES PRIOR TO ATTACHING THE DISSECTION TIP TO THE 7MM SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 25019740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA