BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM ENDOSCOPE

    MDR report key: 13804964 · Received March 18, 2022

    Report

    Report Number
    3001722928-2022-00004
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    January 27, 2022
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDS
    PMA / PMN Number
    K172916
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER VISITED THE HOSPITAL AND INSPECTED THE ENDOSCOPE INVOLVED IN THIS EVENT, BUT NO ABNORMALITIES WERE FOUND IN THE IMAGE. THE ENDOSCOPE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION, BUT THE MALFUNCTION COULD NOT BE REPRODUCED. EC-760ZP-V/M IS NOT CLEARED TO BE MARKETED IN THE U.S. BUT IS SIMILAR TO EC-760ZP-V/L THAT HAS A 510(K).

    Additional Manufacturer Narrative · 0

    ON JUNE 17, 2022, FUJIFILM CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION. A REVIEW OF THE ERROR LOG CONFIRMED THAT A COMMUNICATION ERROR OCCURRED BETWEEN THE SCOPE AND THE PROCESSOR. FUJIFILM ATTEMPTED TO REPRODUCE THE ERROR BY CONNECTING THE SCOPE WITH THE PROCESSOR, BUT THE ERROR COULD NOT BE REPRODUCED. THE ENDOSCOPE WAS DISASSEMBLED AND INVESTIGATED, BUT NO ABNORMALITY WAS FOUND. AS SUCH, FUJIFILM COULD NOT DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO FDA AS A RESULT OF FUJIFILM CORPORATION'S COMMITMENT TO PERFORM A RETROSPECTIVE REVIEW OF ALL MDRS SUBMITTED BETWEEN OCTOBER 1, 2021 AND OCTOBER 12, 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON SEPTEMBER 22, 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE. THE MODEL EC-760ZP-V/M IS NOT FDA-CLEARED UNDER 510(K) K191747; WHICH WAS LISTED IN BLOCK G4 OF THE ORIGINAL MDR; HOWEVER, IT IS VERY SIMILAR TO THE MODEL EC-760ZP-V/L , WHICH WAS CLEARED UNDER 510(K) K191747.

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM CORPORATION BECAME AWARE OF AN ADVERSE EVENT RELATED TO EC-760ZP-V/M THAT OCCURRED WHILE PERFORMING AN ENDOSCOPIC MUCOSAL RESECTION (EMR). IT WAS REPORTED THAT THE IMAGE BECAME ABNORMAL DURING THE EMR. THE PHYSICIAN PERFORMING THE PROCEDURE ATTEMPTED TO TROUBLESHOOT THE PROBLEM BY POWER-CYCLING THE DEVICE, BUT THE IMAGE DID NOT RETURN TO ITS NORMAL STATE. THE SCOPES WERE SWITCHED OUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO INJURY OR DEATH INVOLVED. AS SUCH, THIS CASE IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41726 FUJIFILM ENDOSCOPE ENDOSCOPE FDS FUJIFILM CORPORATION EC-760ZP-V/M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown