MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546650
Medical Device Problem Codes	Poor Quality Image (1408); Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: subsequent product codes kqm, ntn.Block h6: imdrf device code f1001 captures the reportable event of absence of treatment.
Event or Problem Description
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.

• Brand Name: SPYGLASS DS
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24259765
• Report Number: 3005099803-2026-00448
• Device Sequence Number: 9649349
• Product Code: FBN
• UDI-Device Identifier: 08714729874348
• UDI-Public: (01)08714729874348(11)150623(10)1517400017
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00546650
• Device Catalogue Number: M00546650
• Device Lot Number: 1517400017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 06/23/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown