BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 20752205 · Received November 21, 2024

    Report

    Report Number
    3005099803-2024-05906
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 24, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 (DEVICE CODES): PROBLEM CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR-QUALITY IMAGE INSIDE THE PATIENT. H11: THE RETURNED EXALT MODEL D SCOPE WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. THE INVESTIGATION WAS UNABLE TO IDENTIFY ANY DAMAGE OR MALFUNCTION RELATED TO THE REPORTED EVENT. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS NO PROBLEM DETECTED, WHICH INDICATES THAT THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED.

    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 CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, POOR VISUALIZATION AND A RED/ORANGE COLORATION WAS REPORTED MAKING IT VERY DIFFICULT TO DISTINGUISH STRUCTURES. 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, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, POOR VISUALIZATION AND A RED/ORANGE COLORATION WAS REPORTED MAKING IT VERY DIFFICULT TO DISTINGUISH STRUCTURES. 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
    2014672 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0034548423 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown