BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DS

    MDR report key: 24247296 · Received February 3, 2026

    Report

    Report Number
    3005099803-2026-00430
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 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
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6 (IMPACT CODES): IMDRF IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE. BLOCK H2: ADDITIONAL INFORMATION BLOCK B5 (DESCRIBE EVENT OR PROBLEM) CORRECTION TO BLOCK B3 (DATE OF EVENT) CORRECTION BLOCK D2B: SUBSEQUENT PRODUCT CODES KQM, NTN CORRECTION TO BLOCK D4 (LOT NUMBER AND SERIAL NUMBER) CORRECTION TO BLOCK E1 (INITIAL REPORTER ZIP/POST CODE) BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT OF CONTROLLER POOR QUALITY IMAGE COULD NOT BE CONFIRMED. WITHOUT A PRODUCT RETURNED, NO PRODUCT ANALYSIS COULD BE CONDUCTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE SPY DS CONTROLLER USED TOGETHER WITH THE TWO SPYSCOPE DS II DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER AND THE TWO SPYSCOPE DS II WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF STRICTURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPYSCOPE DS II DID NOT DISPLAY AN IMAGE. A SECOND SPYSCOPE DS II WAS THEN USED, BUT THE IMAGE STILL FAILED TO APPEAR. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE SPY DS CONTROLLER USED TOGETHER WITH THE TWO SPYSCOPE DS II DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER AND THE TWO SPYSCOPE DS II WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF STRICTURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPYSCOPE DS II DID NOT DISPLAY AN IMAGE. A SECOND SPYSCOPE DS II WAS THEN USED, BUT THE IMAGE STILL FAILED TO APPEAR. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. *ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026* THE CHOLANGIOSCOPY PROCEDURE TOOK PLACE ON (B)(6) 2026. BOTH SCOPES WERE TESTED WITH ANOTHER SPY DS CONTROLLER AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311139 SPYGLASS DS CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC CORPORATION M00546650 1515200071 08714729874348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown