BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DS

    MDR report key: 25338419 · Received May 29, 2026

    Report

    Report Number
    3005099803-2026-02219
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 25, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729874348
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTROLLER DEVICE WAS INTENDED FOR USE DURING A CHOLANGIOSCOPY PROCEDURE IN THE BILE DUCT ON (B)(6) 2026, FOR THE TREATMENT OF BILE DUCT STONES. DURING THE PROCEDURE, THE CONTROLLER WAS CONNECTED AND TESTED; HOWEVER, THE POWER BUTTON ILLUMINATED FOR APPROXIMATELY 10 SECONDS AND THEN UNEXPECTEDLY SHUT DOWN. TROUBLESHOOTING WAS PERFORMED, INCLUDING DISCONNECTING AND RECONNECTING THE SPYSCOPE, AS WELL AS UNPLUGGING AND RECONNECTING THE CONTROLLER, BUT THESE EFFORTS WERE UNSUCCESSFUL. AS A RESULT, THE PROCEDURE WAS CANCELED, AND THE PATIENT WILL BE RESCHEDULED FOR A REPEAT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591827 SPYGLASS DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546650 1832000061 08714729874348

    Patients

    Seq Age Sex Outcome Treatment
    1