BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DS

    MDR report key: 24662991 · Received March 23, 2026

    Report

    Report Number
    3005099803-2026-01050
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729874348
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABSENCE OF TREATMENT. BLOCK D2B: SUBSEQUENT PRO CODES KQM, NTN.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIGITAL CONTROLLER WAS USED WITH A SPYSCOPE DS II DURING A CHOLANGIOSCOPY FOR INTERDUCTAL CLEARANCE ON (B)(6) 2026, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, VISUALIZATION WAS LOST. ALTHOUGH SUFFICIENT STONE CLEARANCE WAS ACHIEVED, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT AND THE PATIENT WAS RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725680 SPYGLASS DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546650 2112700023 08714729874348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown