BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1873692 · Received September 21, 2010

    Report

    Report Number
    2242352-2010-02871
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. (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 WOULD NOT ACTIVATE. THIS OCCURRED DURING BRANCH LIGATION EVEN THOUGH THE PRE-CAUTERY TEST WAS SUCCESSFUL. WHEN THEY WANT GO PLACE THE DEFECTIVE HEMOPRO BACK IN THE PLASTIC TRAY, THEY FOUND A PIECE OF METAL AND THEY DID NOT KNOW IF THAT BELONGED TO THE HEMOPRO OR SOMETHING ELSE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING.

    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 25007753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA