BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 23464226 · Received November 4, 2025

    Report

    Report Number
    3005099803-2025-05494
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A06 CAPTURES THE REPORTABLE EVENT OF LOSS OF VISUALIZATION. IMDRF CODE A090208 CAPTURES THE POOR QUALITY IMAGE. BLOCK H11: THE RETURNED EXALT MODEL D SCOPE WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. DURING THE VISUAL INSPECTION, THE SCOPE RETURNED DIDN'T HAVE ANY VISUAL DAMAGE. IN THE IMAGE TEST, THE DEVICE WAS CONNECTED TO THE CONTROLLER AND DISPLAYED THE EXPECTED IMAGE. DURING THE FUNCTIONAL TEST, THE CAMERA TIP WAS ARTICULATED WITHOUT ANY PROBLEMS, THE IMAGE WASN'T LOST DURING THIS TEST. THE IMAGE WASN'T LOST DURING THE FLUSH TEST. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES, THE REPORTED EVENT WAS NOT CONFIRMED. THE PROBABLE CAUSE SELECTED FOR THE VISUALIZATION PROBLEM IS NO PROBLEM DETECTED. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE A06 CAPTURES THE REPORTABLE EVENT OF LOSS OF VISUALIZATION. IMDRF CODE A090208 CAPTURES THE POOR QUALITY IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS UTILIZED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE FLUID WAS FORMING ON LENS AND CONTINUED TO GET WORSE UNTIL IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS UTILIZED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE FLUID WAS FORMING UNDER THE SCOPE'S LENS CAUSING VISUALIZATION TO DETERIORATE. THIS CONTINUED TO GET WORSE UNTIL IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2685275 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0034300235 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown