BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 17967279 · Received October 19, 2023

    Report

    Report Number
    3005099803-2023-05485
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 26, 2023
    Report Date
    December 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    UDI-DI
    08714729993605
    PMA / PMN Number
    K193202
    Removal / Correction Number
    97090504-FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR-QUALITY IMAGE. BLOCK H9 (CORRECTION/REMOVAL REPORTING #). ON OCTOBER 3, 2023, BOSTON SCIENTIFIC ISSUED A PRODUCT REMOVAL NOTICE (97090504-FA) TO RECALL CERTAIN BATCHES OF THE EXALT MODEL D SINGLE-USE DUODENOSCOPE FOLLOWING AN INCREASE IN REPORTS OF POOR IMAGE QUALITY DUE TO FLUID INGRESS IN THE LENS. TO ADDRESS THIS KNOWN, UNCOMMON MALFUNCTION, BOSTON SCIENTIFIC HAS IMPLEMENTED CORRECTIVE CHANGES FOR REPLACEMENT EXALT MODEL D SCOPES. BLOCK H11: BLOCK H6: EVALUATION CONCLUSION CODE CORRECTED BASED ON UPDATED DEVICE EVALUATION. BLOCK H7, H9: WERE CORRECTED, THE REPORTED DEVICE LOT NUMBER WAS IDENTIFIED WITHIN THE BOSTON SCIENTIFIC PRODUCT REMOVAL NOTICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS USED DURING PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR TREATMENT OF STONES ON (B)(6) 2023. UPON SUBMERGING THE SCOPE IN FLUID A HONEYCOMB EFFECT WAS OBSERVED ON THE SCREEN. SUCTION WAS USED TO MINIMIZE THE EFFECT AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE MALFUNCTIONING SCOPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXALT MODEL D SCOPE WAS USED DURING PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR TREATMENT OF STONES ON (B)(6) 2023. UPON SUBMERGING THE SCOPE IN FLUID A HONEYCOMB EFFECT WAS OBSERVED ON THE SCREEN. SUCTION WAS USED TO MINIMIZE THE EFFECT AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE MALFUNCTIONING SCOPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078971 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0031538040 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown