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

Model Number	M00546610
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii and spy ds controller were attempted for use in the common bile duct for stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, after the spyglass was introduced into the cbd, the image became hazy and unclear.Shortly thereafter, the display stopped functioning and several dots appeared on the screen.We attempted to reset the connections, but the same issue persisted.As a result, the procedure was cancelled due to this event.
Additional Manufacturer Narrative
Block e1: the healthcare facility address: (b)(6).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 ; 9145716918
• MDR Report Key: 25446026
• Report Number: 3005099803-2026-02368
• Device Sequence Number: 14893942
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)270502(10)40319853
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: 0040319853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 05/02/2025
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG