BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1934550 · Received November 23, 2010

    Report

    Report Number
    2242352-2010-03421
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE HEATER WAS SHIFTED AND THE JAWS WERE BURNT. THE HOT JAW SILICON WAS CRACKING. THE DEVICE HAD SOME EVIDENCE OF BLOOD. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PERFORM ACCORDING TO SPECIFICATIONS DURING SEVERAL DEVICE ACTIVATIONS, THE DEVICE SELF-ACTIVATED. BASED UPON THE VISUAL OBSERVATIONS AND THE FUNCTIONAL TEST, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM CAUGHT ON FIRE, WAS SMOKING AND RED HOT. THE HARVESTER WAS NOT TOUCHING ANYTHING WHEN IT HAPPENED, AND THE UNIT HAD TO BE UNPLUGGED FROM THE POWER SUPPLY. 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 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25010797

    Patients

    Seq Age Sex Outcome Treatment
    1 NA