BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2033427 · Received March 24, 2011

    Report

    Report Number
    2242352-2011-00181
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE BURNT. THE TIP OF THE COLD JAW SILICON HAD DETACHED AND WAS NOT REC'D. THE MISSING PART OF THE JAW BOOT IS ABOUT .5 CM LONG AND 0.25 CM WIDE. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SILICON JAW BOOT BROKE OFF" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, A PIECE OF THE VASOVIEW HEMOPRO SILICON JAW BOOT BROKE OFF. THE PA ATTEMPTED TO REMOVE IT, BUT COULD NOT RETRIEVE IT. AN X-RAY WAS PERFORMED TO LOCATED THE PIECE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE, TO HARVEST THE OTHER LEG, AS ONLY A SMALL PIECE OF THE TIP HAD DETACHED. THERE WERE NO PT EFFECTS. THE PRODUCT WAS 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 25026753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other