BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12764091 · Received November 7, 2021

    Report

    Report Number
    8010047-2021-14207
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 12, 2021
    Report Date
    January 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170339752
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ CHECKED THE SUBJECT DEVICE AND FOUND THE FOLLOWING. THE RESIDUAL LIQUID OR FOREIGN MATERIAL COME OUT FROM THE AUXILIARY CHANNEL. NO AIR WAS SUPPLIED DUE TO DAMAGE ON THE AIR/WATER CHANNEL. NO WATER WAS SUPPLIED DUE TO DAMAGE ON THE AIR/WATER CHANNEL. THE SUCTION FUNCTION DID NOT WORK AT ALL DUE TO DAMAGE ON THE SUCTION CHANNEL. THE CONTROL SECTION WAS DIRTY. THE SCOPE CONNECTOR WAS DIRTY. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. SINCE THE RELATIONSHIP BETWEEN THE REPORTED MICROBIOLOGICAL TESTING RESULT (POSITIVE) AND THE SUBJECT DEVICE COULD NOT BE DETERMINED BASED UPON THE INFORMATION FROM THE USER AND OAZ, OMSC COULD NOT CONCLUSIVELY DETERMINE THE EXACT CAUSE OF THE REPORTED PHENOMENON. IN ADDITION, THE EXACT CAUSE OF THE REPORTED FOREIGN OBJECTS FROM THE AUXILIARY CHANNEL COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OAZ AND PAST SIMILAR CASES, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING. SINCE THE PRE-CLEANING WAS NOT PERFORMED IMMEDIATELY AFTER EACH PROCEDURE, IT BECAME DIFFICULT TO REMOVE THE FOREIGN MATERIAL. SINCE THE CLEANING BRUSHING AND/OR THE WATER FEEDING WAS NOT PERFORMED PROPERLY DURING THE PRE-CLEANING AND/OR THE MANUAL CLEANING, IT BECAME DIFFICULT TO REMOVE THE FOREIGN MATERIAL. SINCE THE RESIDUAL WATER INSIDE THE AUXILIARY CHANNEL WAS NOT REMOVED PROPERLY AFTER REPROCESSING, THE INSIDE OF THE METALLIC PIPE AT THE DISTAL END WAS CORRODED, AND IT BECAME EASY TO BE ADHERED THE FOREIGN MATERIAL. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). THE EVALUATION IS IN PROGRESS CURRENTLY. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. [FIRST TIME; (B)(6), 2021] - GRAM NEGATIVE BACILLI (10-100 CFU) IDENTIFIED AS SPHINGOMONAS PAUCIMOBILIS [SECOND TIME; (B)(6), 2021] - GRAM POSITIVE COCCI (1 CFU) IDENTIFIED AS ENTEROCOCCUS SPECIES [THIRD TIME; (B)(6), 2021] - GRAM NEGATIVE BACILLI (10-100 CFU) IDENTIFIED AS DELFTIA ACIDOVORANS - GRAM POSITIVE COCCI (10-100 CFU) IDENTIFIED AS ENTEROCOCCUS GALLINARUM - ENTEROCOCCUS FAECALIS (10-100 CFU) THE SUBJECT DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, OER-AW. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657175 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-2TH180 04953170339752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown