BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT? MODEL D

    MDR report key: 22939340 · Received September 2, 2025

    Report

    Report Number
    3005099803-2025-04345
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729983514
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE. E1: THE REPORTED HEALTHCARE FACILITY IS: (B)(6) HOSPITAL. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE SCOPE HAD A LOT OF BUBBLES AND WATER IN THE IMAGE. THE PHYSICIAN CHANGED OUT TO REUSABLE SCOPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249217 EXALT? MODEL D DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542420 08714729983514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown