BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVE 530

    MDR report key: 3845893 · Received May 29, 2014

    Report

    Report Number
    MW5036407
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 27, 2014
    Manufacturer
    FUJINON
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH USE OF A FUJINON EVE (B)(4) SERIES ENDOSCOPE. PT WAS REPORTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE). ENDOSCOPE WAS CULTURED AND PROVED TO BE POSITIVE FOR CRE DESPITE FOLLOWING MFR'S RECOMMENDATIONS FOR HIGH LEVEL DISINFECTION. (B)(4). REPRESENTED IN THE NORTH AMERICA BY FUJINON INC., (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317241 EVE 530 ENDOSCOPE FDS FUJINON EVE 530

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention