BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DS

    MDR report key: 24259765 · Received February 4, 2026

    Report

    Report Number
    3005099803-2026-00448
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 4, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729874348
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: SUBSEQUENT PRODUCT CODES KQM, NTN. BLOCK H6: IMDRF DEVICE CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CONTROLLER WAS ATTEMPTED FOR USE DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILIARY STRICTURE. DURING THE PROCEDURE, THE SPYSCOPE DS CONTROLLER DID NOT DISPLAY AN IMAGE ON THE MONITOR. AFTER INSPECTION, IT APPEARED THAT THERE WAS NOT A PROPER CONNECTION AT THE PORT WHERE THE CATHETER IS CONNECTED TO THE CONTROLLER. THE PHYSICIAN WAS UNABLE TO COMPLETE THE ERCP DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321988 SPYGLASS DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546650 1517400017 08714729874348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown