BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2233019 · Received July 19, 2011

    Report

    Report Number
    8010047-2011-00164
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 20, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 IT WAS UNK AS TO HOW LONG THE STENT HAD BEEN LODGED INSIDE THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE. THE ENDOSCOPE HAD REPORTEDLY BEEN USED MULTIPLE TIMES PRIOR TO THE STENT DISLODGING, AND THERE HAD BEEN NO REPORTS OF BLOCKAGE PRIOR TO THE PROCEDURE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE INSTRUMENT CHANNEL AND THE SUCTION CHANNEL OF THE SUBJECT DEVICE WERE INSPECTED WITH A BOROSCOPE. NO DAMAGE, RESTRICTIONS, OR FOREIGN OBJECTS WERE OBSERVED IN THE INSTRUMENT CHANNEL. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED PHENOMENON APPEARS TO BE DUE TO INADEQUATE REPROCESSING. AN OLYMPUS ENDOSCOPE SVC SPECIALIST HAS BEEN DISPATCHED TO REVIEW APPROPRIATE REPROCESSING ENDOSCOPES WITH THE USER FACILITY. THE DEVICE HAS BEEN SERVICED AND RETURNED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, A BOSTON SCIENTIFIC ESOPHAGEAL STENT DISLODGED FROM THE ENDOSCOPE AND FELL INTO THE PT'S BODY CAVITY. THE STENT WAS REPORTEDLY RETRIEVED WITH AN UNIDENTIFIED GRASPING DEVICE. THERE WERE NO REPORTS OF PT INFECTION OR CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE FDS OLYMPUS MEDICAL SYSTEM CORPORATION GIF-XTQ160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1