BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2012198 · Received February 1, 2011

    Report

    Report Number
    2242352-2011-00012
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 3, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE TOOL, SOME SIGNS OF CLINICAL USAGE, AND THE DEVICE HAD SOME EVIDENCE OF BLOOD. RESISTANCE MEASUREMENTS MET SPECIFICATIONS. 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, IT PRODUCED STEAM. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "WOULD NOT ACTIVATE" WAS NOT CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS A 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 DEVICE WOULD NOT ACTIVATE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT 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 25021702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA