BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2093547 · Received April 6, 2011

    Report

    Report Number
    2242352-2011-00236
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE INSIDE TIP OF THE COLD JAW SILICONE BOOT WAS DETACHED AND THE DETACHED PIECE WAS NOT RECEIVED. THE TOP WAS PEELING. THE HEATING ELEMENTS WERE LIFTED UP SOMEWHAT. THE JAWS WERE SOMEWHAT BURNT. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "JAW BOOT CAME 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, THE VASOVIEW HEMOPRO COATING ON THE TIP CAME OFF. THERE WERE NO PATIENT 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA