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	03/19/2026
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 intended for use during a cholangioscopy procedure on (b)(6) 2026 for the treatment of a stone in the hepatic duct.Upon connecting the spyscope and proceeding with the procedure, the image was lost.Attempts were made to reconnect and adjust the device; however, the issue persisted.The device was removed, resulting in loss of positioning, and a new spyscope was opened.The same issue occurred with the second scope.As the patient was under general anesthesia, the procedure could not be completed and had to 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 evaluation 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 image loss during the procedure could not be confirmed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during production that could explain the event.The review ensures each device meets specification prior to release for use, and there is no indication that the device manufacturing process contributed to the reported complaint.A risk review confirmed that the event of procedure cancellation or rescheduling post sedation is documented within the product risk files and has been considered in the overall risk-benefit assessment, which remains acceptable.Additionally, a labeling review verified that the instructions for use provide adequate guidance, and there is no evidence of improper use or deficiencies in labeling that could have contributed to the event.Based on the available information, there is insufficient evidence to determine the exact cause of the reported image loss during the cholangioscopy procedures involving two devices.Therefore, the most probable cause cannot be established.As a direct consequence of the inability to complete the procedure under general anesthesia, the event of procedure 'cancelled/rescheduled - post sedation/sedation unknown' will be classified as 'adverse event related to procedure'.
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 intended for use during a cholangioscopy procedure on (b)(6) 2026 for the treatment of a stone in the hepatic duct.Upon connecting the spyscope and proceeding with the procedure, the image was lost.Attempts were made to reconnect and adjust the device; however, the issue persisted.The device was removed, resulting in loss of positioning, and a new spyscope was opened.The same issue occurred with the second scope.As the patient was under general anesthesia, the procedure could not be completed and had to be rescheduled.No patient complications were reported as a result of 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: 24845812
• Report Number: 3005099803-2026-01322
• Device Sequence Number: 5624394
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)260912(10)40234137
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/15/2026

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 Expiration Date: 09/12/2026
• Device Model Number: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 0040234137
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 09/12/2024
• 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