BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE MODEL ED-580T

    MDR report key: 17684082 · Received September 5, 2023

    Report

    Report Number
    3001722928-2023-00051
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    June 21, 2023
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    04547410330649
    PMA / PMN Number
    K191747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 ED-580T DUODENOSCOPE IS NOT FDA-CLEARED UNDER 510(K) K191747; WHICH WAS LISTED IN BLOCK G4 OF THE ORIGINAL MDR 3001722928-2023-00051; HOWEVER, IT IS VERY SIMILAR TO THE MODEL ED-580XT DUODENOSCOPE, WHICH WAS CLEARED UNDER 510(K) K191747. MDR SUPPLEMENT 3001722928-2023-00051 S1 INDICATED IN BLOCK G4 THAT THE DEVICE IS A COMBINATION PRODUCT. THIS IS INCORRECT. IT IS NOT A COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 0

    FUJIFILM INVESTIGATED THE DEVICE AND FOUND NO ABNORMALITY WITH THE EQUIPMENT. FUJIFILM CONFIRMED THAT THERE WAS NO PROBLEM WITH THE ABILITY TO ATTACH AND DETACH THE CAP.

    Additional Manufacturer Narrative · 0

    SINCE THE ED-580T IS SIMILAR TO THE ED-580XT, FUJIFIM SUBMIT THIS MDR. A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ON (B)(6), 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING ED-580T. IT WAS REPORTED THAT WHILE A YOUNG PHYSICIAN BEGAN INSERTING A DUODENOSCOPE ED-580T INTO A PATIENT, THE PHYSICIAN, ACCIDENTALLY INSERTED THE DUODENOSCOPE INTO THE BRONCHUS. THE PHYSICIAN REMOVED THE ENDOSCOPE AND INSERTED IT INTO THE DUODENUM, THEN PLACED AN ENBD TUBE AFTER ERCP AND COMPLETED THE ENDOSCOPY. ON (B)(6), THE PHYSICIAN PERFORMED HIGH-FREQUENCY COAGULATION ON THE WOUND ON THE STOMACH. A CT SCAN WAS ALSO PERFORMED ON THE BRONCHI. THE CAP WAS EXHALED WHEN THE DISCHARGED PATIENT COUGHED. ON (B)(6), THE PATIENT VISITED THE HOSPITAL WITH A CAP. A CT IMAGE TAKEN ON (B)(6) WAS CONFIRMED AGAIN, AND IT WAS FOUND THAT THE CAP WAS LEFT BEHIND IN THE BRONCHI. THE PATIENT HAS NOT COMPLAINED OF ANY HEALTH HAZARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560116 FUJIFILM DUODENOSCOPE MODEL ED-580T DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580T N/A 04547410330649

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other