BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1844756 · Received September 23, 2010

    Report

    Report Number
    2242352-2010-02879
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 25, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON SEPTEMBER 1, 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE COLD JAW WAS BURNT AND THERE WAS SOME EVIDENCE OF BLOOD. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DURING SEVERAL DEVICE ACTIVATIONS, THE DEVICE PRODUCED STEAM AND DID NOT REMAIN ACTIVATED. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "REMAINED ACTIVATED" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE RETURNED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, DURING BRANCH LIGATION, IT WAS NOTED THAT THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM CONTINUED ACTIVATION AFTER REMOVAL FROM THE PT. THE DEVICE WAS IMMEDIATELY DISCONNECTED. THERE WAS NO INJURY TO THE PT NOR THE STAFF. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 25017218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA