BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM UPPER G.I. TRACT ZOOM SCOPE EC-L600ZP7

    MDR report key: 16542537 · Received March 14, 2023

    Report

    Report Number
    3001722928-2023-00008
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 14, 2023
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    04547410331905
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, FUJIFILM CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION OF EC-L600ZP7. THE REPORTED MALFUNCTION COULD NOT BE REPRODUCED AND FURTHER INSPECTION DID NOT REVEAL ANY ABNORMALITIES. THEREFORE, THE INVESTIGATION CONCLUDES THAT THERE IS NO DEVICE PROBLEM.

    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.

    Additional Manufacturer Narrative · 0

    THE SCOPE WAS INSPECTED BY THE USER AT THEIR FACILITY AFTER IT WAS REMOVED FROM THE PATIENT, BUT THE FAILURE WAS NOT ABLE TO BE REPRODUCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS. EC-L600ZP7 IS NOT SOLD IN THE UNITED STATES; HOWEVER, IT SHARES THE SAME HANDLE DESIGN AS OTHER FUJIFILM SCOPES THAT ARE SOLD IN THE UNITED STATES.

    Description of Event or Problem · 0

    ON FEBRUARY 15, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING EC-L600ZP7. IT WAS REPORTED THAT DURING A COLONOSCOPY, THE ANGLE PORTION FAILED AND LOCKED IN POSITION WHILE INSIDE THE PATIENT. THE OVERTUBE WAS ATTACHED TO THE SCOPE AND INSERTED, UNLOCKING THE ANGLE PORTION. THE USER SWITCHED OUT THE SCOPE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY. THERE IS NO DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720089 FUJIFILM UPPER G.I. TRACT ZOOM SCOPE EC-L600ZP7 DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT FUJIFILM CORPORATION N/A N/A 04547410331905

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female