BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    MDR report key: 3912160 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00562
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    July 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOPRO 2 DEVICE WAS RETURNED OT THE FACTORY FOR EVALUATION. THERE WERE NO SIGNS OF CLINICAL USAGE AND NO EVIDENCE OF BLOOD. A VISUAL INSPECTION IDENTIFIED THAT THE SILICONE BOOT OF THE COLD SIDE OF THE JAW WAS DAMAGED. THE PROXIMAL PORTION OF THE SHAFT WAS BENT APPROXIMATELY 30 DEGREES. ADDITIONAL EVALUATION REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    WHEN THE STERILE PACK WAS REMOVED FROM BOX, IT WAS NOTICED BY THE NURSE THAT THE VASOVIEW HEMOPRO 2 WITH VASOSHIELD CAUTERY WAS BENT AND INSULATION DAMAGED ABOUT AN INCH BACK FROM THE TIP. THE DEVICE WAS NOT OPENED TO THE STERILE FIELD AND IT WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285301 VASOVIEW HEMOPRO 2 WITH VASOSHIELD ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4001 25091513

    Patients

    Seq Age Sex Outcome Treatment
    1