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

Model Number	M00546780
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Investigation results summary: the spy discover catheter was not returned as it was disposed.A product analysis could not be performed.Therefore, the reported events of spyscope poor quality image and inadequate lighting could not be confirmed due to the lack of evidence.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event the reported event of cancelled /rescheduled post sedation/sedation unknown occurred during the procedure.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific that a spyscope was utilized in a common bile duct exploration procedure on (b)(6) 2026.During the procedure the scope was plugged in and there were no issues were present at first.After a few minutes the lighting the scope made it difficult to see anything.The staff plugged the scope out and back in to see if that changed anything and adjusted lighting on the controller with no success.Physician was unable to complete successful cbde due to that being the only scope available.The patient had to undergo a cholangiography with post operative endoscopic retrograde cholangiopancreatography (ercp).Procedure was cancelled.No patient complications were reported as a result of the 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: 25352718
• Report Number: 3005099803-2026-02248
• Device Sequence Number: 10302245
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)270908(10)40373684
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 0040373684
• 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: 05/04/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 09/08/2025
• 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