BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1900590 · Received October 29, 2010

    Report

    Report Number
    2242352-2010-03211
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 1, 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
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THE COLD JAW WAS BURNT, HALF OF THE HOT JAW SILICON WAS DETACHED, AND THE REMAINING SILICON WAS CRACKED. THERE WAS SOME EVIDENCE OF BLOOD. 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 THE VISUAL OBSERVATIONS, THE REPORTED FAILURE, "DEVICE OVERHEATED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMITY 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, WHILE THE USER FINISHED THE DISSECTION PROCEDURE AND STARTED TO HARVEST THE GRAFT, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM SELF ACTIVATED, OVERHEATED AND SCORCHED THE TIP ON THE SIDE OF THE WIRED JAW. THE HEMOPRO WAS CONNECTED TO THE POWER SUPPLY WITH THE POWER SET AT 3. A REPLACEMENT UNIT 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-W 25006533

    Patients

    Seq Age Sex Outcome Treatment
    1 NA