BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 23873103 · Received December 22, 2025

    Report

    Report Number
    3005099803-2025-06835
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: IMDRF CODE A090208 CAPTURES THE REPORTABLE EVENT OF LOSS OF VISUALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2025, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE THE IMAGE WAS INITIALLY FUZZY AND PROGRESSIVELY WORSENED THROUGHOUT THE CASE, ULTIMATELY DISPLAYING A HONEYCOMB-LIKE PATTERN ON THE SCREEN BY THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715679 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0037351867 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown