BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 3946385 · Received July 10, 2014

    Report

    Report Number
    8010047-2014-00407
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED TJF-Q180V WAS RETURNED TO (B)(4) FOR EVALUATION. THE EVALUATION CONFIRMED BROWN STAIN AND BLACK FOREIGN MATERIAL ON THE INSTRUMENT CHANNEL. IN ADDITION, THERE WAS BLACK STAIN ON THE SUCTION CHANNEL. THE EXACT CAUSE OF USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF SIGNIFICANT AND ADDITIONAL INFORMATION BECOMES AVAILABLE LATER/ PLEASE CROSS-REF THE FOLLOWING REPORTS FOR THE OTHER THREE PATIENTS: 8010047-2014-00393, 8010047-2014-00408, AND 8010047-2014-00409.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT FOUR PATIENTS TESTED POSITIVE FOR CARBAPENEM RESISTANT KLEBSIELLA PNEUMONIA AFTER HAVING UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PATIENTS WERE EXAMINED WITH THE SAME DUODENOVIDEOSCOPE. THE USER FACILITY CONDUCTED A CONTROL TEST ON THE ENDOSCOPE ON (B)(4) 2014, AND KLEBSIELLA PNEUMONIA WAS FOUND. THE LAST ROUTINE SAMPLING OF THE ENDOSCOPE ON (B)(4) 2014 DID NOT INDICATE ANYTHING ABNORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403876 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOENDOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-Q180V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other