BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS DUODENOVIDEOSCOPE

    MDR report key: 1781479 · Received July 29, 2010

    Report

    Report Number
    8010047-2010-00152
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION WITH THIS MATTER, AN OLYMPUS' ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND TO ADDRESS THE REPORTED PHENOMENON. THE ESS WAS INFORMED THAT THE SUBJECT ENDOSCOPE WAS LOANER DEVICE. THE ESS DETERMINED THAT THE FACILITY PERFORMED A LEAK TEST AND PLACED THE LOANER ENDOSCOPE IN THE STERIS SYSTEM 1 WITHOUT PERFORMING A PRECLEANING AND MANUAL CLEANING. THE ESS WAS ABLE TO REMOVE A YELLOW SPONGE LIKE MATERIAL FROM THE INSTRUMENT CHANNEL USING A BIOPSY FORCEPS (MODEL UNKNOWN, WHICH LIKELY CAUSED THE RESTRICTIONS NOTED BY THE USERS DURING THE PROCEDURE. THE ESS FURTHER REPORTED THAT NOTHING REPORTEDLY FELL INTO THE PATIENT. THE USER FACILITY CLAIMED THAT THEY DO NOT USE THESE TYPES OF SPONGES. THE CHANNEL WAS CLEARED AND THE DEVICE WAS REPROCESSED. THE DEVICE WAS THEN RETURNED TO OLYMPUS FOR INVESTIGATION. THE EVALUATION CONFIRMED THAT THERE WAS NO RESTRICTION OR BLOCKAGE OBSERVED WHEN THE ENDOSCOPE WAS TESTED USING A BIOPSY FORCEPS. THE INSTRUMENT AND SUCTION CHANNEL WAS EXAMINED USING A BOROSCOPE AND THERE WAS NO PROBLEM FOUND. THE ENDOSCOPE PASSED THE AIR/WATER LEAK TEST. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, DEVIATIONS FROM THE RECOMMENDED REPROCESSING PROCEDURES COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THE USERS EXPERIENCE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE USER WAS UNABLE TO PASS AN UNSPECIFIED INSTRUMENT THROUGH THE INSTRUMENT CHANNEL OF THE ENDOSCOPE DUE TO A RESTRICTION. THE USERS ATTEMPTED TO PASS ANOTHER INSTRUMENT THROUGH THE INSTRUMENT CHANNEL SEVERAL TIMES BUT NO RESULT. THE ENDOSCOPE WAS WITHDRAWN FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FAK OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-140F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED INSTRUMENT WAS SAID TO HAVE BEEN USED| DURING THE PROCEDURE.