BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 17952896 · Received October 17, 2023

    Report

    Report Number
    3005099803-2023-05497
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR TREATMENT OF STRICTURE ON (B)(6) 2023. THREE MINUTES INTO THE PROCEDURE, THE SCOPES IMAGE BEGAN TO DETERIORATE AFTER CANNULATION. ADDITIONALLY, A YELLOW BAR POPPED UP NEXT TO THE IMAGE AND THE IMAGE COLOR BEGAN TO CHANGE. THE PROCEDURE WAS COMPLETED USING A REUSABLE SCOPE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750114 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0032047032 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown