BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1812185 · Received August 17, 2010

    Report

    Report Number
    2242352-2010-02455
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(4), 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE JAWS WERE SOMEWHAT BURNT AND BLOODY, AND WERE DIFFICULT TO OPEN AND CLOSE. RESISTANCE MEASUREMENTS WERE NOT WITHIN SPECIFICATIONS. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PERFORM ACCORDING TO SPECIFICATIONS DURING SEVERAL DEVICE ACTIVATIONS. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT "STOPPED WORKING" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM STOPPED WORKING AFTER HARVESTING ON ONE OF THE PATIENT'S LEGS HAD BEEN COMPLETED. A NEW KIT WAS OPENED TO HARVEST THE OTHER LEG AND COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. 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, LLC VH-3000 25011477

    Patients

    Seq Age Sex Outcome Treatment
    1 NA