BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS OES CHOLEDOCHOFIBERSCOPE

    MDR report key: 2140343 · Received June 16, 2011

    Report

    Report Number
    8010047-2011-00131
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 18, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT SECTION OF INSERTION TUBE COVER FELL INTO THE PT'S ABDOMINAL CAVITY CLOSE TO THE GALLBLADDER. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS AMERICA INC FOR EVAL. THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. IF SIGNIFICANT AND RELEVANT INFO BECOME AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A SECTION OF THE INSERTION TUBE OUTER COVER FELL INTO THE PT'S BODY CAVITY. THE DETACHED COVER WAS REPORTEDLY RETRIEVED WITH UNIDENTIFIED TYPE FORCEPS. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PT WAS REPORTEDLY IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES CHOLEDOCHOFIBERSCOPE CHOLEDOCHOSCOPE FBN OLYMPUS MEDICAL SYSTEMS CORPORATION CHF-XP20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1