BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 7192492 · Received January 15, 2018

    Report

    Report Number
    2951238-2018-00035
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 22, 2017
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    PK093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) ON-SITE FINDINGS AND THE INDEPENDENT LABORATORY RESULTS. ON FEBRUARY 7, 2017, THE ESS COMPLETED THE ONSITE REPROCESSING TRAINING AND OBSERVATION OF THE USER FACILITY¿S REPROCESSING PRACTICES. THERE WERE NO DEVIATIONS NOTED. AS PART OF OUR INVESTIGATION, THE SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR MICROBIAL TESTING. THE SCOPE TESTED POSITIVE FOR MICROCOCCUS LUTEUS, BACILLUS AMYLOLIQUEFACIENS, BACILLUS ATROPHAEUS, AND STAPHYLOCOCCUS WARNERI. THE SCOPE WAS THEN ETHYLENE OXIDE (ETO) STERILIZED AND RETURNED TO OLYMPUS. BASED ON THE FINDINGS FROM THE INDEPENDENT LABORATORY, IMPROPER MAINTENANCE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE REPORTED POSITIVE CULTURE. THE INSTRUCTION AND REPROCESSING MANUAL STATES, ¿THE PROBABILITY OF FAILURE OF THE ENDOSCOPE AND ANCILLARY EQUIPMENT INCREASES AS THE NUMBER OF PROCEDURES PERFORMED AND/OR THE TOTAL OPERATING HOURS INCREASE. IN ADDITION TO THE INSPECTION BEFORE EACH PROCEDURE, THE PERSON IN CHARGE OF MEDICAL EQUIPMENT MAINTENANCE IN EACH HOSPITAL SHOULD INSPECT THE ITEMS SPECIFIED IN THIS MANUAL PERIODICALLY. AN ENDOSCOPE WITH AN OBSERVED IRREGULARITY SHOULD NOT BE USED. ALL CHANNELS OF THE ENDOSCOPE, INCLUDING THE INSTRUMENT CHANNEL AND THE AUXILIARY WATER CHANNEL, AND ALL ACCESSORIES USED WITH THE ENDOSCOPE DURING THE PATIENT PROCEDURE, SUCH AS ALL VALVES AND THE AUXILIARY WATER TUBE (MAJ-855), MUST BE CLEANED AND HIGH-LEVEL DISINFECTED OR STERILIZED AFTER EACH PATIENT PROCEDURE, EVEN IF THE CHANNELS OR ACCESSORIES WERE NOT USED DURING THE PATIENT PROCEDURE. INSUFFICIENT CLEANING AND DISINFECTION OR STERILIZATION OF THESE COMPONENTS MAY POSE AN INFECTION CONTROL RISK TO PATIENTS AND/OR OPERATORS.¿

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM ITX TO ODG.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE INTERNAL CHANNELS OF THE DEVICE WAS INSPECTED USING A BORESCOPE; THERE WERE EXCESSIVE GREENISH STAINS NOTED INSIDE THE BIOPSY CHANNEL WALL BELOW THE PROTECTOR BOOT. THE BIOPSY CHANNEL WALL WAS TORN NEAR THE DISTAL END. THERE WERE NO FOREIGN MATERIAL OR SUBSTANCE NOTED INSIDE THE DEVICE CHANNELS, AND OTHER PARTS OF THE DEVICE. IN ADDITION, THE BENDING SECTION COVER GLUE FROM THE DISTAL END AND INSERTION TUBE SIDE ARE BOTH DISCOLORED. THE USER FACILITY FURTHER REPORTED THAT THE RESULTS OF THE SECOND CULTURE WAS NEGATIVE. HOWEVER, PER CUSTOMER'S REQUEST THE DEVICE WILL BE FORWARDED TO AN OFF-SITE LABORATORY FOR MICROBIOLOGICAL TESTING. AS PART OF OUR INVESTIGATION INTO THIS REPORT, AN ESS HAS BEEN DISPATCHED TO THE USER FACILITY TO REASSESS REPROCESSING THEIR PRACTICES, AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. HOWEVER, THE ON-SITE VISIT HAS NOT YET BEEN FINALIZE. THIS REPORT WILL BE UPDATED IF NEW INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE DEVICE CULTURE TESTED (B)(6) FOR (B)(6). THERE WAS NO PATIENT INFECTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34019 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180

    Patients

    Seq Age Sex Outcome Treatment
    1