BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXALT MODEL D SINGLE-USE DUODENOSCOPE

    MDR report key: 17952704 · Received October 17, 2023

    Report

    Report Number
    3005099803-2023-05561
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 27, 2023
    Report Date
    January 4, 2024
    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
    WA, 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. 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) WAS CORRECTED BASED ON UPDATED PRODUCT INVESTIGATION PERFORMED ON DECEMBER 11, 2023.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A090208 CAPTURES THE REPORTABLE EVENT OF POOR QUALITY IMAGE. BLOCK H9 (CORRECTION/REMOVAL REPORTING #): ON (B)(6), 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.

    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 (ERCP), FOR TREATMENT OF BILIARY OBSTRUCTION ON (B)(6) 2023. DURING TESTING PRIOR TO THE PROCEDURE, WATER INGRESS WAS OBSERVED UNDER THE SCOPE'S LENS. THE PHYSICIAN BEGAN THE PROCEDURE USING THIS SCOPE. WHILE THE SCOPE WAS IN THE PATIENT'S DUODENUM, WATER INGRESS WORSENED, AND THE IMAGE DETERIORATED. THEREFORE, ANOTHER EXALT MODEL D SCOPE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE 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 (ERCP), FOR TREATMENT OF BILIARY OBSTRUCTION ON (B)(6) 2023. DURING TESTING PRIOR TO THE PROCEDURE, WATER INGRESS WAS OBSERVED UNDER THE SCOPE'S LENS. THE PHYSICIAN BEGAN THE PROCEDURE USING THIS SCOPE. WHILE THE SCOPE WAS IN THE PATIENT'S DUODENUM, WATER INGRESS WORSENED, AND THE IMAGE DETERIORATED. THEREFORE, ANOTHER EXALT MODEL D SCOPE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078611 EXALT MODEL D SINGLE-USE DUODENOSCOPE DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION M00542421 0031828975 08714729993605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown