BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 8360644 · Received February 21, 2019

    Report

    Report Number
    8010047-2019-01132
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Report Date
    March 20, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305153
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT "510(K) NUMBER" OF G5 AND TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. THE USER FACILITY REPORTED THAT THE PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS WERE DETECTED FROM UNSPECIFIED CHANNEL(S) OF THE SUBJECT DEVICE (ON (B)(6) AND (B)(6) 2019) AND THE UNSPECIFIED BACTERIA WAS DETECTED FROM THE INSERTION TUBE. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL MINI-ETD 2 (NOT AVAILABLE IN THE USA) WITH PERACETIC ACID. THE USER FACILITY ALSO REPORTED DEVIATIONS FROM THE INSTRUCTIONS OF THE SUBJECT DEVICE IN THEIR REPROCESSING PROCEDURE AS FOLLOWS. THE BIOPSY VALVE, AIR/WATER VALVE, AND THE SUCTION VALVE OF THE SUBJECT DEVICE HAD NOT BEEN BRUSHED. THE WATER BOTTLE, WHICH WAS USED WITH THE SUBJECT DEVICE DURING PROCEDURE, HAD NOT BEEN REPROCESSED. THE ENDOSCOPES WERE NOT STORED IN STORAGE CABINET AFTER REPROCESSING. IT WAS UNKNOWN WHETHER THE ENDOSCOPE WERE DRIED BEFORE THE STORAGE. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT WAS RETURNED TO OLYMPUS EUROPE HOLDING (OEH). OEH SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, THE TEST RESULT INDICATED NO MICROBIAL GROWTH FOR THE SAMPLES COLLECTED FROM THE DISTAL END, THE INSTRUMENT CHANNEL, AIR/WATER CHANNEL, AND THE AUXILIARY WATER CHANNEL OF THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS EVALUATED BY THE OEH. THE EVALUATION RESULT ARE AS FOLLOWS; THE LIGHT GUIDE LENS OF THE SUBJECT DEVICE WAS CRACKED AND THE GLUE AROUND THE LENS WAS DETERIORATED AND BECAME POROUS. THE DISTAL END WAS DAMAGED. THE GLUE AROUND THE BENDING SECTION RUBBER WAS PARTIALLY PEELED OFF. THE AIR/WATER CYLINDER AND THE SUCTION CYLINDER AT THE CONTROL SECTION CORRODED. THE S-CORD CONNECTOR MOUNT, THE LIGHT GUIDE, THE AIR PIPE, ELECTRICAL CONTACTS, PLUG UNIT, AND VENTING CONNECTOR OF THE ENDOSCOPE CONNECTOR CORRODED. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT THE INAPPROPRIATE REPROCESSING PRACTICE AND MAINTENANCE AT THE USER FACILITY CANNOT BE RULED OUT AS A POSSIBLE CAUSE. THE INSTRUCTION HAS ALREADY WARNS AND INSTRUCTS; ¿INSUFFICIENT BRUSHING MAY POSE AN INFECTION CONTROL RISK.¿ ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ "MAKE SURE TO CAREFULLY INSPECT EACH PIECE OF ENDOSCOPIC EQUIPMENT FOR IRREGULARITIES (DAMAGE) PRIOR TO EACH PATIENT PROCEDURE. DO NOT USE THE EQUIPMENT IF ANY IRREGULARITY IS OBSERVED."

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. [FIRST TIME; (B)(6) 2019] PSEUDOMONAS AERUGINOSA. [SECOND TIME; (B)(6) 2019] (THE MICROBES WERE NOT SPECIFIED.) [THIRD TIME; (B)(6) 2019] STAPHYLOCOCCUS AUREUS. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150612 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190L 04953170305153

    Patients

    Seq Age Sex Outcome Treatment
    1