BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 20579278 · Received October 31, 2024

    Report

    Report Number
    3005099803-2024-05209
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 (DEVICE CODES): PROBLEM CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE INSIDE THE PATIENT. BLOCK H11: THE RETURNED EXALT MODEL D SCOPE WAS ANALYZED. OIL RESIDUES WERE FOUND OUTSIDE THE CAMERA LENS, THEREFORE, SOME STAINS COULD BE OBSERVED DURING THE VISUALIZATION TEST. ONCE THE CAMERA LENS WAS CLEANED, THE IMAGE WAS DISPLAYED AS EXPECTED. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS ADVERSE EVENT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    BLOCK H6 (DEVICE CODES): PROBLEM CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR-QUALITY IMAGE INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN OIL SPOT WAS RIGHT IN THE MIDDLE OF THE IMAGE COVERING THE AMPULLA MAKING VISUALIZATION VERY TOUGH. THE LENS WAS RINSED AND WIPED BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN OIL SPOT WAS RIGHT IN THE MIDDLE OF THE IMAGE COVERING THE AMPULLA MAKING VISUALIZATION VERY TOUGH. THE LENS WAS RINSED AND WIPED BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011511 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0034071657 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown