BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS DUODENOVIDEOSCOPE

    MDR report key: 1873517 · Received October 13, 2010

    Report

    Report Number
    8010047-2010-00212
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 14, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFO REGARDING THIS REPORT. OLYMPUS WAS INFORMED THAT THE PT WAS ADMITTED FOLLOWING THE PROCEDURE ON (B)(6) 2010 FOR OBSERVATION. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL NOTED RESTRICTION INSIDE THE SUCTION CHANNEL AT THE CONTROL BODY. ADDITIONALLY, MULTIPLE KINKS WERE OBSERVED ON THE SUCTION CHANNEL WALL AT THE CONTROL BODY. THE REPORTED PHENOMENON APPEARS TO BE DUE TO PHYSICAL DAMAGE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, AS THEY NOTICED BLEEDING FROM A SMALL FROND-LIKE MASS ON THE AMPULLA, THE PROCEDURE WAS CONVERTED TO THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). A BIOPSY FORCEPS WAS ABLE TO BE ADVANCED DOWN THE ENDOSCOPE ON AN INITIAL PASS, HOWEVER, THE USER CLAIMED TO BE UNABLE TO ADVANCE THE ENDOTHERAPY DEVICES ON SUBSEQUENT ATTEMPTS. THE PT WAS ADMITTED AND RE-EXAMINED THE FOLLOWING DAY, AND THE PHYSICIAN WAS REPORTEDLY SATISFIED WITH THE CONTROL OF THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS DUODENOVIDEOSCOPE DUODENOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION JF-130 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC RADIAL JAW FORCEPS