BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2193026 · Received July 21, 2011

    Report

    Report Number
    2242352-2011-00982
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE JAWS HAD NO NON CONFORMITIES AND SOME SIGNS OF CLINICAL USAGE. THERE WAS MINIMAL EVIDENCE OF BLOOD. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECIFICATIONS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ACCORDING TO SPECIFICATIONS DURING THE DEVICE ACTIVATION. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "KEPT SHUTTING OFF" 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 VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 POWER WOULD SHUT OFF, BUT THE USER WAS NOT OVERBURNING. IT WOULD JUST STOP. ONE TIME THE USER DID NOT BURN AND WAITED OVER 30 SECONDS, BUT THE PROBLEM PERSISTED ANYWAY. THE REPORTED KIT WAS USED TO COMPLETE THE PROCEDURE SOME DIFFICULTY. 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 25034100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA