BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 12744546 · Received November 3, 2021

    Report

    Report Number
    8010047-2021-13996
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 6, 2021
    Report Date
    January 11, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170363672
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS AUSTRALIA AND NEW ZEALAND (OAZ) FOR EVALUATION. OAZ REQUESTED THE FACILITY THREE TIMES TO PROVIDE THE INFORMATION REGARDING REPROCESSING, HOWEVER THE FACILITY DID NOT PROVIDE AND OAZ COULD NOT OBTAIN IT. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OAZ AND THE INSTRUCTION FOR USE (IFU), OMSC SURMISED THAT THE AIR/WATER NOZZLE WAS CLOGGED WAS ATTRIBUTED TO THE FOLLOWINGS. - THERE WAS A DIFFERENCE BETWEEN THE USER'S REPROCESSING AND THE IFU DESCRIPTION. - THERE WAS A LACK OF DEVICE HANDLING AND THE CLEANING, DISINFECTION AND STERILIZATION (CDS) TRAINING FOR THE FACILITY STAFF IN ACCORDANCE WITH THE IFU.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4) AND (B)(4) FOR EVALUATION. (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE AIR/WATER NOZZLE WAS CLOGGED (HAD BLOCKAGE) WHICH CAUSED THAT AIR/WATER SUPPLY VOLUME AND WATER REMOVAL DID NOT MEET THE STANDARD VALUE. ALSO (B)(4) FOUND THE FOLLOWINGS. THERE WAS LEAKING FROM THE GLUE OF THE BENDING RUBBER. THE INSULATION OF THE DISTAL END RESISTANCE VALUE WAS OUT OF SPECIFICATION. THE ANGULATIONS WAS OUT OF SPECIFICATION. THE BENDING SECTION WAS HEAVY, TENSION OR HAS POOR BENDING FORM. THE GLUE OF THE RUBBER WAS DETACHED, CHIPPED, CRACKED, OR HAS A BURR. THE ANGULATION CONTROL KNOBS WERE NOT LOCKING. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING 3 OR 4 TIMES BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. IN ADDITION, OMSC WAS INFORMED THAT FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. [(B)(6) 2021] PSEUDOMONAS AERUGINOSA (>100CFU) 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
    1643456 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190DL 04953170363672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown