BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 3850590 · Received May 22, 2014

    Report

    Report Number
    2951238-2014-00219
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 2, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. AS PART OF OUR INVESTIGATION WITH THIS REPORT, OLYMPUS REPRESENTATIVES VISITED THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES. THERE WERE MINOR DEVIATIONS NOTED DURING THE REPROCESSING OF THE DEVICE. IT WAS NOTED THAT THE USER FACILITY HAD NO SUCTION IN THE REPROCESSING ROOM AND THE STAFF WERE NOT USING A SYRINGE TO FLUSH AROUND THE FORCEPS ELEVATOR RISER AREA. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE LATER. PLEASE CROSS-REFERENCE THE FOLLOWING REPORTS FOR THE OTHER ELEVEN CASES: 2951238-2014-00174, 00211, 00212, 00213, 00220, 00220, 00221, 00221, 00222, 00223, 00224, 00225 AND 00226.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT TWELVE PATIENTS TESTED POSITIVE FOR ESCHERICHIA COLI (E COLI) CONTAINING EXTENDED-SPECTRUM BETA LACTAMASE (ESBL) AFTER HAVING UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE POSITIVE CULTURES WERE ISOLATED FROM THE PATIENT'S BLOOD, PSEUDOCYST, AND BILE. THE PATIENTS WERE EXAMINED WITH FOUR DIFFERENT DUODENOVIDEOSCOPES. THESE DUODENOVIDEOSCOPES WERE CULTURED TWICE BY THE USER FACILITY. NO ORGANISMS WERE ISOLATED. ON (B)(6) 2014, THE FIFTH PATIENT UNDERWENT AN ERCP. AFTER THE PROCEDURE, THE PATIENT TESTED POSITIVE FOR RESISTANT E COLI. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306678 OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION TJF-Q180V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CUSTOM ULTRASOUND REPROCESSOR