BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3960115 · Received June 23, 2014

    Report

    Report Number
    2242352-2014-00702
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL CALLED SEEKING A SHIP DATE OF BOM 7MM EXTENDED LENGTH ENDOSCOPE. THE HOSPITAL REPORTED THAT THEY WERE HAVING A "PROBLEM WITH THE SCOPE." THE SCOPE IS NOT RETURNING. THE HOSPITAL WAS UNABLE TO PROVIDE THE EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364757 BOM 7MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VH-1111

    Patients

    Seq Age Sex Outcome Treatment
    1