BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM ENDOSCOPE MODELS EC-760R-V/M

    MDR report key: 18976302 · Received March 25, 2024

    Report

    Report Number
    3001722928-2024-00011
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 20, 2024
    Report Date
    December 27, 2024
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    UDI-DI
    04547410458817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE EC-760R-V/M IS SIMILAR TO EC-760R-V/L(510(K) NUMBER: K172916), FUJIFILM SUBMIT THIS MDR. ONCE FUJIFILM OBTAINS THE FORCEPS CHANNEL THAT WAS POSITIVE FROM THE SERVICE CENTER, IT WILL BE INVESTIGATED. THE SUPPLEMENTAL MDR WILL BE SUBMITTED IF THE ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    AS DEVIATIONS WERE FOUND IN THE CLEANING PROCEDURES AT THE FACILITY, TRAINING WAS CONDUCTED. DAMAGE WAS OBSERVED IN THE FORCEPS CHANNEL. THE ENDOSCOPE WAS REPAIRED BY REPLACING THE FORCEPS CHANNEL. THE CULTURE TEST AFTER THE ENDOSCOPE REPAIR WAS NEGATIVE. DEVIATION FROM THE CLEANING PROCEDURE AND DAMAGE TO THE FORCEPS CHANNEL ARE POSSIBLE CAUSES OF THE POSITIVE RESULT, BUT IT WAS NOT POSSIBLE TO DETERMINE THIS. THE UDI# LISTED IN D4 IS THE UDI# FOR THE COUNTRY WHERE THE EVENT OCCURRED AND IS DIFFERENT FROM THE UDI-DI IN THE UNITED STATES. THE UDI-DI FOR THIS PRODUCT IN THE UNITED STATES IS (B)(4).

    Description of Event or Problem · 0

    THIS FACILITY PERFORMS ROUTINE ENDOSCOPIC CULTURES MONTHLY. SINCE THE CULTURE OF THIS DEVICE WAS POSITIVE, TWO MORE CULTURE TESTS WERE PERFORMED AND BOTH OF THE RESULTS WERE POSITIVE. THIS FACILITY REQUESTED THE SERVICE CENTER TO REPLACE THE FORCEPS CHANNEL THAT HAD TESTED POSITIVE. NO HEALTH HAZARDS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409319 FUJIFILM ENDOSCOPE MODELS EC-760R-V/M COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF FUJIFILM CORPORATION EC-760R-V/M 04547410458817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown