BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 19458574 · Received June 4, 2024

    Report

    Report Number
    3005099803-2024-02568
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 10, 2024
    Report Date
    June 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (DEVICE CODES): PROBLEM CODE A06 CAPTURES THE REPORTABLE EVENT OF LOSS OF VISUALIZATION INSIDE THE PATIENT. PROBLEM CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXALT MODEL D SINGLE USE SCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STENT REMOVAL ON (B)(6)2024. DURING THE PROCEDURE, THE PHYSICIAN PROCEEDED TO GET INTO POSITION. THE IMAGE ON THE MONITOR BEGAN TO FLICKER ON AND OFF CAUSING DISTORTED IMAGES. THE SCOPE WAS UNPLUGGED AND RE-PLUGGED BUT THE IMAGE WAS NEVER RECOVERED AFTER TROUBLESHOOTING. IT WAS ALSO REPORTED THAT THE SCOPE'S ELEVATOR WAS DIFFICULT TO ACTUATE. THE PROCEDURE WAS COMPLETED WITH A REUSABLE SCOPE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150028 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0030281814 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown