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

Model Number	M00546610
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii device was used during a cholangioscopy-guided lithotripsy procedure on (b)(6) 2026, for the treatment of a common bile duct stone.During the procedure, visualization was lost approximately 10 minutes after the scope was in use.Troubleshooting was performed, including powering off the controller and restarting it; however, these efforts were unsuccessful.As a result, the procedure was canceled, and the patient will be rescheduled.No patient complications were reported in connection with this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.H2: device analysis: the complaint device was not returned for evaluation; therefore, product analysis could not be performed, and the reported event could not be confirmed due to lack of evidence.A review of the device history record confirmed that the device met manufacturing specifications prior to distribution, with no process-related non-conformances, scrap, or rework identified that could explain the event.A risk review confirmed that the event cancelled/rescheduled - post sedation/sedation unknown is documented in the product risk files and has been included in the risk-benefit analysis, with an acceptable residual risk for the device.Based on the available information, there is insufficient evidence to determine the exact cause of the loss of visualization; therefore, cause not established was identified as the most probable cause.As this was a direct consequence of loss of visualization, the event cancelled/rescheduled - post sedation/sedation unknown will be classified as adverse event related to procedure.No further escalation is required.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii device was used during a cholangioscopy-guided lithotripsy procedure on (b)(6) 2026, for the treatment of a common bile duct stone.During the procedure, visualization was lost approximately 10 minutes after the scope was in use.Troubleshooting was performed, including powering off the controller and restarting it; however, these efforts were unsuccessful.As a result, the procedure was canceled, and the patient will be rescheduled.No patient complications were reported in connection with this event.

• 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: 25048836
• Report Number: 3005099803-2026-01610
• Device Sequence Number: 18756330
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)271204(10)40412398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/01/2026

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: 0040412398
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 06/25/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/12/2026; 07/01/2026
• Date Device Manufactured: 12/04/2025
• 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 Sex: Unknown