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

Model Number	M00546610
Medical Device Problem Codes	Device-Device Incompatibility (2919); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii device was attempted for use during endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2026, for the treatment of choledocholithiasis.During the procedure, the scope lost visualization while using electrohydraulic lithotripsy (ehl).Troubleshooting steps were attempted to resolve the issue, including unplugging and replugging the scope in.A balloon sweep was then attempted but was unsuccessful at removing the stone.The physician was unable to complete the procedure due to this event.A stent was place and the patient will be rescheduled for another ercp no patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): h6 imdrf device code f1001 captures the reportable event of absence of treatment.The product was not returned for evaluation; therefore, no analysis could be performed to determine whether a device defect was present or to confirm the reported event.Due to the lack of available evidence, the complaint could not be verified.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Additionally, a review of the device history and risk documentation for the spyscope ds ii confirms that the event cancelled/rescheduled post sedation/sedation unknown has been previously identified and accounted for within the product risk analysis, with an overall acceptable risk-benefit profile.In the absence of a direct device evaluation, the root cause of the reported issue cannot be established; therefore, unable to exclude device problem is identified as the most probable cause.As the procedure was not completed due to the conditions encountered, the event 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: 24733149
• Report Number: 3005099803-2026-01143
• Device Sequence Number: 10192176
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)271106(10)40400995
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 0040400995
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/06/2025
• 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