BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1842154 · Received August 31, 2010

    Report

    Report Number
    2242352-2010-02621
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 2, 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: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(4), 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT JAWS OF THE HEMOPRO WERE CHARRED AND SLIGHTLY BURNT. THE JAWS SHOWED SIGNS OF CLINICAL USAGE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. RESISTANCE MEASUREMENTS WERE WITHIN SPECIFICATION. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DURING SEVERAL DEVICE ACTIVATIONS. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "WOULD NOT DISENGAGE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM WOULD NOT DISENGAGE; IT REMAINED ON CONTINUOUSLY. THE DEVICE WAS UNPLUGGED, REMOVED, AND ANOTHER VASOVIEW HEMOPRO DEVICE WAS USED TO COMPLETE THE CASE. THE HOSP REPORTED NO PT EFFECT. 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 25012356

    Patients

    Seq Age Sex Outcome Treatment
    1 NA