BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19473054 · Received June 5, 2024

    Report

    Report Number
    2429304-2024-0000293
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    September 1, 2022
    Report Date
    June 5, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EVIDENCE OF TRANSMISSION OF NEW DELHI METALLO- LACTAMASE PRODUCING KLEBSIELLA PNEUMONIAE THROUGH A GASTROINTESTINAL ENDOSCOPE WITHOUT AN ELEVATOR CHANNEL." ABSTRACT: OBJECTIVE: TO INVESTIGATE THE SOURCE AND TRANSMISSION DYNAMICS OF AN ENDOSCOPE-ASSOCIATED NEW DELHI METALLO-LACTAMASE-PRODUCING KLEBSIELLA PNEUMONIA (NDM-KP) OUTBREAK. DESIGN: EPIDEMIOLOGICAL AND GENOMIC INVESTIGATION. SETTING: ACADEMIC ACUTE CARE HOSPITAL IN NEW JERSEY. PATIENTS: FIVE PATIENTS WITH ACTIVE NDM-KP INFECTION IDENTIFIED ON CLINICAL ISOLATES, AND FOUR NDM-KP COLONIZED PATIENTS IDENTIFIED VIA RECTAL SWAB SCREENING. RESULTS: OVER A TWELVE-MONTH PERIOD, NINE PATIENTS WERE IDENTIFIED WITH NDM-KP INFECTION OR COLONIZATION. WHOLE-GENOME SEQUENCING (WGS) REVEALED THAT ALL OF THE IDENTIFIED CASES WERE RELATED BY 25 MUTATIONAL EVENTS OR LESS. SEVEN OF THE CASES WERE LINKED TO GASTROINTESTINAL ENDOSCOPIC PROCEDURES (FOUR CLINICAL CASES AND THREE POSITIVE SCREENS AMONG PATIENTS EXPOSED TO ENDOSCOPES SUSPECTED OF TRANSMISSION). TWO CASES DEMONSTRATED DELAYED TRANSMISSION THAT OCCURRED FIVE MONTHS AFTER THE INITIAL OUTBREAK, LIKELY THROUGH SHARED USAGE OF A NON-THERAPEUTIC GASTROSCOPE WITHOUT AN ELEVATOR CHANNEL. CONCLUSIONS: ALTHOUGH ALL ENDOSCOPE CULTURES IN OUR INVESTIGATION WERE NEGATIVE, THE EPIDEMIOLOGICAL LINK TO GASTROINTESTINAL ENDOSCOPES, THE HIGH DEGREE OF RELATEDNESS VIA WGS, AND THE IDENTIFICATION OF ASYMPTOMATIC NDM-KP COLONIZATION AMONG PATIENTS EXPOSED TO SHARED ENDOSCOPES MAKE THE ENDOSCOPIC MODE OF TRANSMISSION MOST LIKELY. THIS INVESTIGATION HIGHLIGHTS THE PROBABLE TRANSMISSION OF NDM-KP VIA A GASTROSCOPE WITHOUT AN ELEVATOR CHANNEL, OBSERVED SEVERAL MONTHS AFTER AN INITIAL OUTBREAK. WE HYPOTHESIZE THAT PERSISTENT MECHANICAL DEFECTS MAY HAVE CONTRIBUTED TO THE DELAYED DEVICE-RELATED TRANSMISSION OF NDM-KP. PATIENT CLINICAL CULTURE C5. POSITIVE CULTURE FOR NEW DELHI METALLO-LACTAMASE-PRODUCING KLEBSIELLA PNEUMONIAE (NDM-KP) SOURCE OF CULTURE - PLEURAL AND PERITONEAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055319 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other