BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DS

    MDR report key: 24649147 · Received March 20, 2026

    Report

    Report Number
    3005099803-2026-01032
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729874348
    PMA / PMN Number
    K183636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: SUBSEQUENT PRODUCT CODES KQM, NTN. BLOCK E1: THE REPORTED HEALTHCARE FACILITY IS: (B)(6). BLOCK H6 (IMPACT CODES): IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE. BLOCK H11: INVESTIGATION RESULTS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS TO IDENTIFY ANY DEFECT WITH THE DEVICE. WITHOUT A PRODUCT RETURNED, NO PRODUCT ANALYSIS COULD BE CONDUCTED. THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. SINCE THE INVESTIGATION FINDINGS CANNOT CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE, AND THE DEVICE WAS NOT RECEIVED FOR PROPER EVALUATION, THE INVESTIGATION CONCLUSION CODE SELECTED FOR THIS COMPLAINT IS UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES WERE USED IN THIS EVENT, THREE SPYSCOPE DS II AND ONE SPYGLASS DS CONTROLLER. THIS RECORD REPRESENTS SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CONTROLLER AND THREE SPYSCOPE DS II WERE ATTEMPTED FOR USE IN THE BILE DUCT DURING A CHOLANGIOSCOPE PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, NO IMAGING WAS OBTAINED, AND THREE DIFFERENT CATHETERS WERE ATTEMPTED. THE PROCEDURE WAS NOT COMPLETED 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
    713891 SPYGLASS DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546650 1514200013 08714729874348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown