BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 3652381 · Received January 31, 2014

    Report

    Report Number
    2951238-2014-00040
    Event Type
    Other
    Date Received
    January 31, 2014
    Report Date
    January 14, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE DEVICE REPAIR HISTORY WAS NOT ABLE TO BE REVIEWED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. THIS REPORT WILL BE SUPPLEMENTED IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A DUODENDOVIDEOSCOPE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIA. THE DUODENDOVIDEOSCOPE WAS REPROCESSED IN THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) PRIOR TO CONDUCTING THE TEST. THE USER FACILITY HAS TWO AER'S AND IT'S UNK IN WHICH ONE THE DUODENDOVIDEOSCOPE WAS REPROCESSED. THERE WAS NO PT INFECTION ASSOCIATED WITH THIS REPORT. OLYMPUS FOLLOWED UP WITH THE USER FACILITY IN AN EFFORT TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT. NO ADD'L INFO HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67524 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS AMERICA, INC. TJF-Q180V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OER-PRO S/N # (B)(4) (2951238-2014-00041)| OER-PRO S/N # (B)(4) (2951238-2014-00040)