BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 61268 · Received August 9, 1996

    Report

    Report Number
    2429304-1996-01826
    Event Type
    Other
    Date Received
    August 9, 1996
    Date of Event
    July 22, 1996
    Report Date
    August 7, 1996
    Manufacturer
    OLYMPUS OPTICAL CO LTD.
    Product Code
    FET
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A DIFFICULT ERCP, WHILE ANOTHER CO'S BILIARY STENT WAS IN PLACE AND AS THE RN ATTEMPTED TO DEPLOY THE STENT UNDER THE DIRECTION OF SALES REP, THE STENT SNAPPED AND BROKE. THE STAFF WAS UNABLE TO DETERMINE IF THE ENTIRE PRODUCT WAS RETRIEVED AT THAT TIME BECUASE THE SALES REP TOOK THE BROKEN STENT WITH HIM. THE SCOPE WAS THEN SENT TO CO FOR REPAIR DUE TO A BROKEN ELEVATOR AND NO PIECE OF THE BROKEN STENT WAS FOUND. SEVERAL MONTHS LATER, DURING AN ERCP, THE BROKEN PIECE OF A WALL STENT FREED ITSELF AND LODGED IN THE PT'S DUODENUM. THE STENT WAS REMOVED WITH SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FET OLYMPUS OPTICAL CO LTD. TJF-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other