MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS? DISCOVER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00546780
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
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.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 could not 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 the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Based on the available information, there is insufficient evidence to determine the exact cause; therefore, unable to exclude device problem was identified as the most probable cause.
Event or Problem Description
It was reported to boston scientific corporation that a spyglass discover device was attempted for use during a cholecystectomy procedure on (b)(6) 2026, for the treatment of choledocholithiasis.During the procedure, the scope lost visualization.Troubleshooting steps were performed to resolve the issue, including unplugging and reconnecting all connections, restarting the controller, and cleaning the scope.Despite these efforts, the physician was unable to complete the cholecystectomy due to this event.The patient was sent for a post operative endoscopic retrograde cholangiopancreatography for treatment.No patient complications were reported as a result of this event.

• Brand Name: SPYGLASS? DISCOVER
• 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: 24513624
• Report Number: 3005099803-2026-00830
• Device Sequence Number: 15883882
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)271114(10)40404969
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200483
• 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): 03/04/2026

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: M00546780
• Device Catalogue Number: M00546780
• Device Lot Number: 0040404969
• 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: 02/15/2026
• Initial Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 11/14/2025
• 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