BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO TISSUE WELDER

    MDR report key: 1760918 · Received July 14, 2010

    Report

    Report Number
    2242352-2010-01883
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Report Date
    June 15, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(4), 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO TISSUE WELDER MALFUNCTIONED. THE REPORTER CLARIFIED THAT "THE DEVICE DID NOT WORK AT ALL." THIS HAPPENED AS THE HARVESTER WAS GOING TO TAKE BRANCHES. THEY SWITCHED CORDS BUT THAT DIDN'T WORK. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL REPORTED NO PATIENT EFFECTS. THE EXACT EVENT DATE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE INCIDENT TOOK PLACE DURING THE WEEK OF (B)(6), 2010. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO TISSUE WELDER TISSUE WELDER GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25009237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA