BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2030558 · Received March 18, 2011

    Report

    Report Number
    2242352-2011-00156
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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
    WI, 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, AND THE HANDLE WAS BLOODY. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED 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 PERFORMED ACCORDING TO SPECIFICATIONS DURING THE DEVICE ACTIVATION. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "NOT CUTTING AS WELL" 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. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 WAS NOT CUTTING AS WELL. THE HARVESTER DID THE FIRST BRANCH AND THERE WAS SOME BLEEDING WHICH WAS RESOLVED BY THE CAUTERY DEVICE. THE NEXT BRANCH WAS FINE, BUT ON THE THIRD BRANCH THE DEVICE HIT THE SHORT CYCLE AROUND 3-4 SECONDS. THE HARVESTER DID A COUPLE MORE BRANCHES BEFORE SWITCHING TO HEMOPRO 1 TO THE 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 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25028331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other