BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 7993000 · Received October 22, 2018

    Report

    Report Number
    2951238-2018-00637
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Report Date
    March 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE ENDOTHERAPY SUPPORT SPECIALIST (ESS) CONTACTED THE USER FACILITY TO OFFER IN-SERVICE. THE USER FACILITY DECLINED. THE USER FACILITY STATED THAT THE SCOPE WILL BE RECULTURED AND THEN WILL BE HANDLED PER THE HOSPITAL'S ESTABLISHED POLICY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF DEVICE EVALUATION AND INDEPENDENT LABORATORY ANALYSIS. THE SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR MICROBIAL TESTING. THE TESTING CONFIRMED THE PRESENCE OF A POSITIVE CULTURE. THE TESTING FOUND STAPHYLOCOCCUS HOMINIS, MICROCOCCUS LUTEUS, DELFTIA LACUSTRIS, DELFTIA TSURUHATENSIS, MICROBACTERIUM LIQUEFACIENS, MICROBACTERIUM MARITYPICUM, MICROBACTERIUM OXYDANS AND STAPHYLOCOCCUS EPIDERMIDIS IN DIFFERENT AREAS OF THE SCOPE. AFTER ETO STERILIZATION, THE SCOPE RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION FOUND SEVERAL BLACK STAINS ON THE INSIDE OF THE INSTRUMENT CHANNEL AT THE BIOPSY ENTRY SIDE AND IN THE MIDDLE SECTION. THE POTENTIAL CAUSE FOR THE STAINS IS CHEMICAL RESIDUE NOT REMOVED DURING REPROCESSING. AS PREVENTIVE MEASURES, THE SCOPE INSTRUCTION MANUAL CONTAINS WARNING STATEMENTS TO MITIGATE AGAINST CROSS CONTAMINATION AND EQUIPMENT DAMAGE: ¿AFTER USING THIS INSTRUMENT, REPROCESS AND STORE IT ACCORDING TO THE INSTRUCTIONS GIVEN IN THE ENDOSCOPE¿S COMPANION REPROCESSING MANUAL. IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION CONTROL RISK, CAUSE EQUIPMENT DAMAGE OR REDUCE PERFORMANCE.¿ BEFORE THE PROCEDURE, ¿INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES.¿ THE REPROCESSING STEPS IN THE INSTRUCTION MANUAL ALSO INCLUDE SEVERAL WARNINGS REGARDING CHANNEL CLEANING, SUCH AS ¿ALL CHANNELS OF THE ENDOSCOPE, INCLUDING THE ELEVATOR WIRE CHANNEL AND BALLOON CHANNEL, MUST BE CLEANED AND HIGH-LEVEL DISINFECTED OR STERILIZED DURING EVERY REPROCESSING CYCLE, EVEN IF THE CHANNELS WERE NOT USED DURING THE PREVIOUS PATIENT PROCEDURE. OTHERWISE, INSUFFICIENT CLEANING AND DISINFECTION OR STERILIZATION OF THE ENDOSCOPE MAY POSE AN INFECTION CONTROL RISK TO THE PATIENT AND/OR OPERATORS PERFORMING THE NEXT PROCEDURE WITH THE ENDOSCOPE.¿

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION; HOWEVER, THE EVALUATION IS PENDING COMPLETION, AS THE INVESTIGATION IS ONGOING. DESPITE SEVERAL FOLLOWUP ATTEMPTS, THERE IS CURRENTLY NO FURTHER INFORMATION REGARDING THE REPORTED POSITIVE CULTURE, THE CUSTOMER REPROCESSING DETAILS, OR THE PRIOR PROCEDURE OR PATIENT. AS PART OF OUR INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WILL BE DISPATCHED TO THE USER FACILITY TO OBSERVE THE USER FACILITY¿S REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING TRAINING AS NECESSARY. THE SUBJECT SCOPE WILL ALSO BE SENT TO AN OFF-SITE INDEPENDENT LABORATORY FOR MICROBIAL TESTING AND ETHYLENE OXIDE (ETO) STERILIZATION. OLYMPUS WILL CONTINUE TO INVESTIGATE AND WORK WITH THE USER FACILITY TO OBTAIN MORE SPECIFIC AND DETAILED INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A POSITIVE CULTURE OCCURRED DURING ROUTINE CULTURING OF THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829797 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1