MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SpyScope? DS II; Choledochoscope And Accessories, Flexible/Rigid

Model Number	M00546610
Medical Device Problem Codes	Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that two spyscope ds ii were attempted for use in the bile duct for stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a second scope was opened after the initial scope lost visualization.The replacement scope provided clear visualization throughout the use of the first ehl probe and for approximately three minutes during use of the second ehl probe before visualization was again lost and five gray dots appeared on the screen.Reportedly, both probes were operated on low power with five pulses.Multiple attempts were made to restore visualization by unplugging the scope and restarting the processor.However, visualization could not be regained.As a result of this event, the physician decided to discontinue the procedure and place two double pigtail stents.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted or cancelled procedure.

• Brand Name: SpyScope? DS II
• Common Device Name: Choledochoscope And Accessories, Flexible/Rigid
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25536388
• Report Number: 3005099803-2026-02503
• Device Sequence Number: 9661485
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)280115(10)40424511
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 0040424511
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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