MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SpyGlass? Discover; choledochoscope and accessories, flexible/rigid

Model Number	M00546780
Medical Device Problem Codes	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	06/02/2026
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
It was reported to boston scientific corporation that a spyglass? discover was used in the large common bile duct during a laparoscopic cholecystectomy procedure for the treatment of biliary stone management performed on (b)(6) 2026.During the procedure, while attempting to access the cystic duct, visualization abruptly displayed three fixed points on the screen, followed by a complete loss of image.The device ceased functioning immediately after this visual disturbance.The problem occurred during active use of the accessory, with continuous irrigation maintained throughout the procedure.No abnormalities had been observed prior to this event.The procedure was not completed due to this event.There were no patient complications 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 ; +1(914)571-6918
• MDR Report Key: 25665623
• Report Number: 3005099803-2026-02622
• Device Sequence Number: 20233127
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)270911(10)40375772
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: 0040375772
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2026
• 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: 06/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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