BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 22440845 · Received July 8, 2025

    Report

    Report Number
    3005099803-2025-03183
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 29, 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

    BLOCK H6 DEVICE CODE A090208 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SCOPE POOR QUALITY IMAGE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A090208 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SCOPE POOR QUALITY IMAGE. BLOCK H11: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THE CUSTOMER PROVIDED SOME PICTURES. A MEDIA INSPECTION WAS PERFORMED, WHERE IT CAN BE OBSERVED AN IMAGE FROM THE PROCEDURE WITH A HONEYCOMB EFFECT AND WITH SOME DOTS ACROSS THE SCREEN. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE SELECTED IS CAUSE NOT ESTABLISHED, SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS TO IDENTIFY ANY DEFECT WITH THE DEVICE. WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXALT MODEL D SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WATER WAS OBSERVED ON THE LENS. THE PHYSICIAN ATTEMPTED A LENS WASH; HOWEVER, THIS DID NOT RESOLVE THE ISSUE, AND A CLEAR IMAGE COULD NOT BE OBTAINED ON THE SCREEN. THE LENS AND CAMERA WERE MANUALLY CLEANED, BUT THE DROPLETS REMAINED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. 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 SINGLE-USE DUODENOSCOPE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WATER WAS OBSERVED ON THE LENS. THE PHYSICIAN ATTEMPTED A LENS WASH; HOWEVER, THIS DID NOT RESOLVE THE ISSUE, AND A CLEAR IMAGE COULD NOT BE OBTAINED ON THE SCREEN. THE LENS AND CAMERA WERE MANUALLY CLEANED, BUT THE DROPLETS REMAINED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340866 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION 42421 0035655441 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown