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
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 device was used during a cholangioscopy procedure on (b)(6) 2026, for the treatment of a stricture.During the procedure, approximately 15 minutes after the scope was in use, visualization was lost.Troubleshooting was attempted, including turning 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 as a result of this event.
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 device was used during a cholangioscopy procedure on (b)(6) 2026, for the treatment of a stricture.During the procedure, approximately 15 minutes after the scope was in use, visualization was lost.Troubleshooting was attempted, including turning 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 as a result of 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 product was not returned for evaluation to determine whether a device defect was present.As a result, no analysis could be performed, and the reported issue of loss of visualization could not be confirmed.A review of the risk documentation for the spyscope ds ii confirmed that the event cancelled/rescheduled - post sedation/sedation unknown is documented accordingly in the product risk records and has been accounted for during product risk analysis to support an acceptable risk-benefit profile for the device.Product risk benefit includes consideration of risk severity and occurrence rate, and the overall residual risk of the device remains acceptable.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on the available information, there is insufficient evidence to determine the exact cause of the reported issue; therefore, cause not established was identified as the most probable cause.As the procedure could not be completed due to the conditions encountered during the event, the impact code cancelled/rescheduled - post sedation/sedation unknown will be classified as adverse event related to 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: 25046210
• Report Number: 3005099803-2026-01606
• Device Sequence Number: 9781206
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)280213(10)40435965
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: 0040435965
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 02/13/2026
• 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