BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM EG-760R GASTROSCOPE

    MDR report key: 12016388 · Received June 17, 2021

    Report

    Report Number
    3001722928-2021-00011
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 17, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDS
    UDI-DI
    04547410358667
    PMA / PMN Number
    K172916
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT THE SUBJECT SCOPE TO A THIRD-PARTY SERVICE PROVIDER BECAUSE A CLEANING BRUSH HAD GOTTEN STUCK IN THE SCOPE. THE SERVICE PROVIDER REMOVED THE BRUSH, REPLACED THE BIOPSY CHANNEL, AND INSPECTED THE REPAIRED SCOPE TO ENSURE THAT THE REPLACED CHANNEL WAS FREE FROM ANY BLOCKAGE. DESPITE THE REPAIR, THE CUSTOMER OBSERVED A BLOCKED CHANNEL BY A BROKEN PART OF A CLEANING BRUSH AFTER INITIAL REUSE OF THE SCOPE. ALTHOUGH FUJIFILM CANNOT IDENTIFY WHEN THE BRUSH PART WAS INTRODUCED IN THE SCOPE CHANNEL, THEY BELIEVE IT MAY HAVE OCCURRED DURING REPROCESSING OF THE SCOPE BY THE CUSTOMER PRIOR TO USE. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. WAS INFORMED OF AN INCIDENT INVOLVING THE (B)(4) GASTROSCOPE. DURING REPROCESSING OF THE SCOPE, A BROKEN PIECE OF A CLEANING BRUSH WAS FOUND IN THE BIOPSY PORT. THERE WAS NO PATIENT INJURY. THE PATIENT WAS TESTED FOR POSSIBLE CROSS-CONTAMINATION, AND THE TEST RESULTS CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917782 FUJIFILM EG-760R GASTROSCOPE GASTROSCOPE AND ACCESSORIES FDS FUJIFILM CORPORATION EG-760R N/A 04547410358667

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR