BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1924644 · Received December 7, 2010

    Report

    Report Number
    2242352-2010-03533
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT AND IT WAS FOUND THAT THERE WERE NO NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, DURING TISSUE DISSECTION, THE TIP OF THE DISSECTION CONE FELL OFF INTO THE PATIENT. IT WAS VISUALIZED AND REMOVED THRU THE SAME INCISION. AN ACCESSORY KIT WAS OPENED AND ANOTHER TIP WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT OR HARM TO THE PATIENT. THE PRODUCT WAS NOT RETURNED.

    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 25021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other