BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO TISSUE WELDER

    MDR report key: 1760965 · Received July 14, 2010

    Report

    Report Number
    2242352-2010-01880
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON JUNE 21, 2010, FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO TISSUE WELDER STARTED BEEPING CONTINUOUSLY AND SMOKING DURING BRANCH LIGATION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE REPORTER STATED THAT THE HOSP DID NOT PERFORM THE PRE-CAUTERY TEST PRIOR TO THE PROCEDURE, AS ADVISED IN THE IFU (INSTRUCTIONS FOR USE). 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