BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 6083385 · Received November 7, 2016

    Report

    Report Number
    2951238-2016-00838
    Event Type
    Death
    Date Received
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK024033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION OR SERVICE, AS THERE WAS NO SPECIFIC SERIAL NUMBER PROVIDED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. AS PART OF OUR INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS REQUESTED TO BE DISPATCHED TO THE USER FACILITY TO ASSESS AND OBSERVE THE FACILITIES REPROCESSING PRACTICE AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. ON (B)(4) 2014 THE USER FACILITY DECLINED THE ON-SITE VISIT.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A LEGAL DOCUMENT ON OCTOBER 17, 2016 ALLEGING THAT A PATIENT DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) INFECTION AFTER UNDERGOING MULTIPLE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES USING AN UNSPECIFIED DUONEVIDEOSCOPE (TJF-Q180V AND/OR TJF-160VF) BETWEEN (B)(6) 2014 AT (B)(6) MEDICAL CENTER IN (B)(6). THE PATIENT EXPIRED ON (B)(6) 2014. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733967 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| O