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

Model Number	M00546780
Medical Device Problem Codes	Material Integrity Problem (2978); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure- post sedation.
Event or Problem Description
Note: this report pertains to one of the two devices used in the same procedure.It was reported to boston scientific corporation that two spyglass discover digital catheters were used for the treatment of choledocholithiasis in the common bile duct during a cholecystectomy and laparoscopic common bile duct exploration (lcbde) procedure performed on (b)(6) 2026.During the procedure, the spyglass light source was connected to a stryker secondary monitor.When the physician attempted to begin scoping, no visualization was observed on the monitor.Multiple dvi cables and monitors were exchanged without restoring image display.A second spyglass discover catheter was opened; however, visualization remained absent.Both spyglass discover catheters exhibited a yellow glow at the connector interface when plugged into the light source.Due to the inability to obtain visualization, the clinical team was unable to complete the cbd exploration.The patient was subsequently referred for a post-operative ercp.No patient complications were reported, and the patient is expected to fully recover.

• 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: 24793854
• Report Number: 3005099803-2026-01230
• Device Sequence Number: 18594382
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)271023(10)40395539
• 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,Followup
• Report Date (Section B): 05/05/2026

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: 0040395539
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 10/23/2025
• 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