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	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a spy discover catheter was utilized during a common bile duct exploration (cbde) procedure on (b)(6) 2026, for the treatment of stones.The scope visualization was lost during the common bile duct exploration (cbde) portion of the procedure.The staff attempted to un-plug and re-plug multiple times, and the scope still did not work.The physician elected to complete procedure without common bile duct exploration (cbde).Common bile duct exploration (cbde) portion of the procedure was unable to be completed as a result of this event, and an endoscopic retrograde cholangiopancreatography (ercp) was scheduled.No patient complications were reported during 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 ; +1(914)571-6918
• MDR Report Key: 25435627
• Report Number: 3005099803-2026-02358
• Device Sequence Number: 10284610
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)271031(10)40398671
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K200483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: 0040398671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 10/31/2025
• 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