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

Model Number	M00546650
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: subsequent product codes kqm, ntn.Block e1: the reported healthcare facility is: (b)(6).Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: investigation results the product was not returned for analysis to identify any defect with the device.Without a product returned, no product analysis could be conducted.The reported event could not be 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.Since the investigation findings cannot confirm the presence or absence of the reported problem with the device, and the device was not received for proper evaluation, the investigation conclusion code selected for this complaint is unable to exclude device problem.
Event or Problem Description
Note: this report pertains to one of four devices were used in this event, three spyscope ds ii and one spyglass ds controller.This record represents spy ds controller.It was reported to boston scientific corporation that a spyscope ds controller and three spyscope ds ii were attempted for use in the bile duct during a cholangioscope procedure on (b)(6) 2026, for the treatment of stones.During the procedure, no imaging was obtained, and three different catheters were attempted.The procedure was not completed due to this event.No patient complications were reported as a result of this event.

• Brand Name: SPYGLASS DS
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24649147
• Report Number: 3005099803-2026-01032
• Device Sequence Number: 10069989
• Product Code: FBN
• UDI-Device Identifier: 08714729874348
• UDI-Public: (01)08714729874348(11)150522(10)1514200013
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: M00546650
• Device Catalogue Number: M00546650
• Device Lot Number: 1514200013
• 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: 02/21/2026
• Initial Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 05/22/2015
• Is the Device Labeled for Single Use? (Y/N): No
• 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