BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 7853447 · Received September 6, 2018

    Report

    Report Number
    2951238-2018-00526
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 17, 2018
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170275449
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDF TO FDS.

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT INCLUDE MICROBIAL TESTING AND THEREFORE THE POSITIVE CULTURE COULD NOT BE CONFIRMED. THE EVALUATION FOUND A SLIGHT DISCOLORATION INSIDE THE BIOPSY CHANNEL ON THE ENTRANCE OF THE BIOPSY PORT. THERE WAS ALSO A BLACK STAIN AT THE ENTRANCE OF THE SUCTION CHANNEL FROM THE SCOPE CONNECTOR SIDE. THERE WAS NO SIGN OF DAMAGE TO THE INSERTION TUBE. THE SCOPE PASSED THE LEAK TEST, AND THE SCOPE IMAGE WAS NORMAL. A REVIEW OF THE DEVICE SERVICE HISTORY SHOWS SEVERAL REPAIRS SINCE THE DEVICE WAS PURCHASED IN MARCH 2012, INCLUDING TWO PRIOR REPAIRS IN 2018. DESPITE SEVERAL FOLLOWUPS BY PHONE AND IN WRITING, NO INFORMATION IS CURRENTLY AVAILABLE REGARDING THE CULTURE RESULTS, DATES, OR RELATIONSHIPS OR IMPACTS TO PROCEDURES AND PATIENTS. THERE IS ALSO NO CURRENT INFORMATION REGARDING USER FACILITY REPROCESSING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A GASTROINTESTINAL VIDEOSCOPE FAILED CULTURE TESTING THREE TIMES AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690479 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180J 04953170275449

    Patients

    Seq Age Sex Outcome Treatment
    1