BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1883014 · Received October 15, 2010

    Report

    Report Number
    2242352-2010-03111
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    May 14, 2010
    Report Date
    September 17, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON SEPTEMBER 24, 2010 FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE JAWS WERE VERY BURNT, AND THE HEATER WAS BOWED OUT SOMEWHAT. THE HOT JAW SILICON WAS CRACKED. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED ENERGY AND STEAM, AND DID NOT REMAIN ACTIVATED. BASED UPON THESE FINDINGS, THE REPORTED FAILURE, "SELF-ACTIVATED" 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TIP ON THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM TURNED RED HOT WHILE IN THE OFF POSITION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE REPORTER WAS UNABLE TO PROVIDE INFO REGARDING THE GAP IN TIME FROM WHEN THE INCIDENT OCCURRED TO WHEN THE EVENT WAS REPORTED. 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 25003700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA