BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 5451728 · Received February 22, 2016

    Report

    Report Number
    2242352-2016-00156
    Event Type
    Malfunction
    Date Received
    February 22, 2016
    Date of Event
    January 26, 2016
    Report Date
    January 26, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02/22/2016 02:10 PM (GMT-5:00) ADDED BY (B)(6): THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. CS-CPL-2016-00067; (B)(6)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT BOM 7MM EXTENDED LENGTH ENDOSCOPE BROKE. THE SCOPE WARRANTY EXPIRED FEBRUARY 16, 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109141 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1