BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 20864159 · Received December 6, 2024

    Report

    Report Number
    3005099803-2024-06115
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 9, 2024
    Report Date
    January 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. WHEN THE SCOPE WAS CONNECTED TO THE CAPITAL EQUIPMENT A "HONEYCOMBING" EFFECT WAS OBSERVED. ONCE THE CAMERA WAS CLEANED, THE IMAGE WAS SHOWN WITH NO VISUAL ISSUES. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT WAS CONFIRMED. 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, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, HONEYCOMBING IN THE IMAGE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH THE SAME EXALT MODEL D 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, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, HONEYCOMBING IN THE IMAGE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH THE SAME EXALT MODEL D SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2471637 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0034819300 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown