BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 16869667 · Received May 4, 2023

    Report

    Report Number
    3002808148-2023-04546
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 4, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170341809
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND PROBLEMS RELATED TO REPROCESSING, THE INSTRUMENT CHANNEL WAS CLOGGED. ADDITONALLY, THE FOLLOWING OBSERVATIONS WERE MADE: THE BODY CONTROL UNIT (BCU) INSERTION TUBE BOOT WAS LEAKING, THE BENDING SECTION COVER (A-RUBBER) GLUE WAS PEELING, THE FORCEPS PASSAGE WAS CLOGGED. THE CHANNEL NEEDED REPLACEMENT, THE SUCTION FLOW SUCTION SHORT TUBE HAD AN INTERNAL SCRATCH WITH BORESCOPE AFTER UNCLOGGED FOD. THE AIR/WATER SUPPLY AUXILLARY PORT WAS CLOGGED, THE LIGHT GUIDE (LG) TUBE HAD SCRATCH MARKS, AND THE CONTROL KNOB HAD PLAY. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE AXIOS METAL STENT WAS LODGED IN THE WORKING CHANNEL OF THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE. THE STENT MISFIRED IN THE SCOPE, DURING A THERAPEUTIC PANCREATIC CYST DRAINAGE. AND THE PHYSICIAN ATTEMPTED TO REMOVE THE DEPLOYMENT SYSTEM AND STENT GOT LODGED IN THE SCOPE. A NEW SCOPE WAS SET UP AND THE PROCEDURE WAS CONTINUED WITH A NEW STENT SYSTEM. THE SECOND STENT WAS NOT DEPLOYED, DUE TO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITHOUT ANY DELAY, HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487395 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170341809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown