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); 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	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter and a spy ds controller were used during a procedure performed on (b)(6) 2026.During the procedure, the image of the spyscope ds ii was not displayed after the spy ds controller light was turned off.The device was plugged in and out, but the light continued to flash continuously, eventually rendering it unusable.The procedure was not completed due to this event.There were no reported patient complications 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.Block h11: investigation results.Based on the available information, the root cause of the loss of visualization and poor-quality image cannot be established, as the product has not been returned for analysis at this time.The device has not been returned for analysis.Therefore, the root cause of the reported observations of loss of visualization and poor quality image cannot be confirmed.A risk review performed for the spyscope ds ii device confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on the available information and in the absence of device return, the root cause of the reported clinical observations for this complaint is unable to exclude device problem.

• 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: 24818364
• Report Number: 3005099803-2026-01272
• Device Sequence Number: 6012269
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)271029(10)40397378
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 0040397378
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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