BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1881692 · Received October 6, 2010

    Report

    Report Number
    2242352-2010-02781
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    August 17, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MAQUET CARDIVASCULAR, 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

    METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP ON THE VASOVIEW HEMPRO EVH SYSTEM WAS ALREADY BROKEN WHEN THE PACKAGE WAS OPENED. THE CONE TIP HAD SEPARATED FORM THE JUICER, BEFORE IT WAS REMOVED FROM THE ACCESSORY TRAY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIVASCULAR, LLC VH-3000 25016908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA