BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2180739 · Received April 29, 2011

    Report

    Report Number
    2242352-2011-00380
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE TOOL WAS RECEIVED INSIDE THE CANNULA. THE SHAFT TIP WAS DETECTED AND BENT, AND THE TIP OF THE SHAFT APPEARED CRACKED. THE JAWS WERE SOMEWHAT BURNT. THERE WAS SOME EVIDENCE OF BLOOD. 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. THE DISTAL JAW TIPS ASSEMBLY AND HANDLE WERE OPENED UP AND THERE WERE NO NON CONFORMITIES. BASED UPON THIS OBSERVATION AND THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "INTERMITTENT CONTINUITY" COULD NOT BE 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 DEVICE WOULDN'T ACTIVATE PROPERLY AFTER INITIAL SHUTDOWN, EVEN AFTER THE 30 SECOND WAIT. THE REPORTER STATED "HE WAS LIGATING BRANCHES WHEN IT SHUT OFF. NO EXCESSIVE SMOKE. HE WAITED 30 SECONDS AND FIRED IT AGAIN. HE SAID THAT HE GOT "ONE BEEP" AND IT SHUT OFF AGAIN. THIS HAPPENED REPEATEDLY AND HE GOT A REPLACEMENT". THE REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED. THE LOT NUMBER GIVEN COULD NOT BE CONFIRMED.

    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