BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 24014462 · Received January 8, 2026

    Report

    Report Number
    3005099803-2026-00128
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELLED RESCHEDULED, POST SEDATION, SEDATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELLED RESCHEDULED, POST SEDATION, SEDATION UNKNOWN. BLOCK H6: IMDRF IMPACT CODE F2203 REMOVED. BLOCK B5: EVENT DESCRIPTION UPDATED.

    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. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A CHALLENGING ANATOMY DUE TO A PANCREATIC MASS. MUCOSAL TRAUMA AND BLEEDING WERE NOTED UPON ADVANCING THE SCOPE. THE PHYSICIAN DISCONTINUED THE PROCEDURE AND SENT THE PATIENT TO INTERVENTIONAL RADIOLOGY WHERE IT WAS CONFIRMED THERE WAS NO PERFORATION. THERE WAS NO INTERVENTION NEEDED FOR THE MUCOSAL TRAUMA OR BLEED.

    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. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE A CHALLENGING ANATOMY DUE TO A PANCREATIC MASS. THE PHYSICIAN REPORTED MUCOSAL TRAUMA AND BLEEDING CAUSED BY THE SCOPE. THE PHYSICIAN DISCONTINUED THE PROCEDURE. THERE WAS NO PERFORATION. THERE WAS NO INTERVENTION NEEDED FOR THE MUCOSAL TRAUMA OR BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74131 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION 42421 0037191226 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male