BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 12873954 · Received November 25, 2021

    Report

    Report Number
    8010047-2021-15076
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Report Date
    January 11, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. AS THE EVALUATION IS IN PROGRESS, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. (THIS REPORT OF 2ND ONE OF 2 ENDOSCOPES WHICH WAS POSITIVE FOR MICROBIOLOGICAL TESTING) OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) GOT THE UPDATED INFORMATION THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING AFER STORAGE OF THE CABINET AT THE USER FACILITY, THE SAMPLE COLLECTED FROM THE INSTRUMENT CHANNEL SURFACE AND DISTAL END OF THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA, C.FREUNDII, SMALTOPHILIA, E.RAFFINOSUS. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, ENDOCLENS, USING OPA (ORTHO-PHTHALALDEHYDE). THE SUBJECT DEVICE WAS INSPECTED AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) AND IT WAS FOUND AS FOLLOWS; -THE CONTROL SECTION HAD SCRATCHES; -THE ADHESIVE OF THE BENDING SECTION RUBBER WAS CRACKED; -THERE WAS LEAKAGE FROM THE ANGULATION CONTROL KNOB; -THE BOOT PART LEADING TO THE BENDING SECTION HAD SCRATCHES; -THE CONNECTOR AND UNIVERSAL CORD HAD SCRATCHES; -THE UNIVERSAL CORD WAS WRINKLED; -THE COLOR PAINT ON THE AIR/WATER CYLINDER AND SUCTION CYLINDER WERE MISSING; -THE IMAGE WAS CLOUDY; -THE INSERTION SECTION HAD SCRATCHES; -THE OBJECT LENS WAS DIRT; -THE BENDING COVER HAD SCRATCHES. FURTHERMORE, THE SUBJECT DEVICE WAS TRANSFERRED TO THE MANUFACTURING SITE TO INVESTIGATE AND FOUND AS FOLLOWS; [INVESTIGATION RESULTS]- -WHEN OBSERVING THE INSIDE OF THE CHANNEL FROM THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END TO THE SUCTION CONNECTOR, NO ABNORMALITIES SUCH AS BUCKLING, DIRT, AND FOREIGN MATERIAL ADHESION COULD BE CONFIRMED. IN ADDITION, NO SIGNIFICANT DIRT OR FOREIGN MATERIAL WAS FOUND AROUND THE INSTRUMENT CHANNEL PORT OR SUCTION CYLINDER. -IT WAS REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. [CONCLUSION]- -THE ROOT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE IDENTIFIED. [CONSIDERATION]- -FROM THE INVESTIGATION RESULTS, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE REPORTED PHENOMENON. -IT WAS NO DEVIATIONS FROM IFU WERE FOUND IN THE USER FACILITY REPROCESS PROCEDURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE 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. ALSO OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT. (THIS REPORT OF 2ND ONE OF 2 ENDOSCOPES WHICH WAS POSITIVE FOR MICROBIOLOGICAL TESTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770842 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown