BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 EVH SYSTEM

    MDR report key: 1935529 · Received December 9, 2010

    Report

    Report Number
    2242352-2010-03271
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED FOR THE PRODUCT, AS THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. INTERNAL FILE NUMBER- (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HARVESTER WAS GETTING LIQUID FAT IN THE TIP WHICH MESSED UP HIS VISION. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE LOT NUMBER AND WHY THE PRODUCT IS NOT RETURNING ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 6 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA