BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2023538 · Received March 16, 2011

    Report

    Report Number
    2242352-2011-00140
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE SOMEWHAT BURNT. THERE WAS SOME EVIDENCE OF BLOOD. JAW FORCE MEASUREMENTS PASSED SPECIFICATIONS. RESISTANCE MEASUREMENTS DID NOT PASS SPECIFICATIONS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND CABLE. THE DEVICE DID NOT PERFORM ACCORDING TO SPECIFICATIONS DURING THE DEVICE ACTIVATION, IT FAILED TO HEAT UP. THE DISTAL JAW TIPS ASSEMBLY WAS OPENED UP AND IT WAS FOUND THAT THE PRIMARY JAW WIRE WAS PARTIALLY DETACHED/LOOSE. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "INTERMITTENT CONTINUITY" WAS CONFIRMED. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 JAWS WORKED ONLY INTERMITTENTLY WHICH CAUSED PROBLEMS IN CAUTERIZING OTHER BRANCHES. IT WAS REPORTED THAT "AFTER THE CASE THERE WAS BLEEDING IN THE AREA WHERE THE HARVESTING WAS DONE AND THE INCISION WAS CLOSED. SOME SEROMAS WERE NOTICED ON THE SKIN OUTSIDE WHERE THE TUNNEL WOULD HAVE BEEN CREATED, AND SOME CELLULITES WERE NOTICED AS WELL. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. LOT NUMBER AND PATIENT STATUS ARE UNKNOWN. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other