BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2080224 · Received April 7, 2011

    Report

    Report Number
    2242352-2011-00333
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT COLD JAW WAS SOMEWHAT BURNT AND THE SILICON APPEARED WORN DOWN SLIGHTLY. THERE WAS EVIDENCE OF BLOOD. THE DEVICE WAS TESTED FOR DEACTIVATION AFTER RELEASING THE TOGGLE. THE DEVICE DID NOT FULLY DEACTIVATE WHEN THE TOOL WAS IN THE CANNULA. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECS. 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 SPECS DURING THE DEVICE ACTIVATION. THE DISTAL JAW TIPS ASSEMBLY AND HANDLE WERE OPENED UP AND THERE WERE NO NON CONFORMITIES. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "TOGGLE SWITCH DID NOT GO OFF" WAS CONFIRMED. THE REPORTED COMPLAINT FOR "ACTIVATION TIME NOT SUITABLE" 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 HEMOPRO2 SPRING IN THE TRIGGER SEEMED INSUFFICIENT TO GET IT TO THE OFF POSITION. THEY HAD TO SET IT TO OFF POSITION MANUALLY. THIS STARTED HAPPENING ABOUT HALFWAY THROUGH THE PROCEDURE AND CONTINUED ABOUT EVERY TIME UNTIL THE END. ALSO EVEN THOUGH IT WAS WORKING UNTIL 14 SEC BEFORE SHUTTING OFF, IT WAS NOT SUITABLE FOR ENDOSCOPIC RADIAL HARVEST. THE 14 SEC WAS NOT ENOUGH TO DO REPORTEDLY STANDARD FASCIOTOMY FOR THE RADIAL HARVEST. AFTER THE FASCIOTOMY WAS DONE, THE ACTIVATION TIMING WAS SUFFICIENT FOR BRANCHES. THE REPORTED UNIT WAS USED TO 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 25027648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA