BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 8369432 · Received February 26, 2019

    Report

    Report Number
    8010047-2019-01149
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 25, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305191
    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. THE USER FACILITY REPORTED THAT THE STAPHYLOCOCCUS EPIDERMIDIS, MICROCOCCUS SP., BREVUNDIMONAS DIMINUTA, AND SPHINGOMONAS PAUCIMOBILIS. WERE DETECTED FROM THE SUBJECT DEVICE (ON (B)(6) 2019). 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 AN ADDITIONAL MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE 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, AND THE EVALUATION CONFIRMED THAT THE GLUE TO FIX THE BENDING RUBBER TO THE INSERTION TUBE OF THE SUBJECT DEVICE WAS WORN AND OUT OF THE PRODUCT STANDARD. NO ANOMALY WAS FOUND OTHER THAN THE GLUE. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAD BEEN MANUAL CLEANING PRACTICE USING AN OLYMPUS BRUSH MODEL BW-422T. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (NOT AVAILABLE IN THE USA) WITH PERACETIC ACID. THE USER FACILITY ALSO REPORTED THAT THE BIOPSY VALVE, AIR/WATER VALVE, AND THE SUCTION VALVE HAD NOT BEEN BRUSHED DURING REPROCESSING. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT THE DEVIATION OF USER¿S REPROCESSING PRACTICE 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.¿

    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 MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. THE USER FACILITY CARRIED OUT REPROCESSING WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, WHEN THEY RECEIVED THE SUBJECT DEVICE AFTER REPAIRING. THE TESTING RESULT WAS WORSE THAN THAT OF FORMER TESTING CONDUCTED BEFORE RETURNING THE SUBJECT DEVICE TO OLYMPUS. THE REPROCESSING PROCEDURE WAS SAME WITH THAT FOR OTHER DEVICES. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162213 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1