BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2153481 · Received June 21, 2011

    Report

    Report Number
    2242352-2011-00667
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE JAWS. THERE WERE MINIMAL SIGNS OF CLINICAL USAGE AND MINIMAL EVIDENCE OF BLOOD. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST, IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS. BASED UPON THE FUNCTIONAL TEST, THE REPORTED FAILURE "FAILURE TO DELIVER ENERGY" COULD NOT BE 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 VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 JAWS CAUTERIZATION STOPPED WORKING DURING SURGERY. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25030603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA