MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYGLASS DS; LED LIGHT SOURCE

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	05/21/2025
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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number: 3005099803-2025-02681 for the spyscope ds ii access & delivery catheter and 3005099803-2025-02683 for the spy ds controller.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the ercp with poc and ehl, the spyglass ds direct visualization system malfunctioned.Attempts to connect the spyscope to the system were unsuccessful, as the light source failed to activate.Despite checking connections and rebooting the system, the issue persisted, preventing the procedure from proceeding.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block g2: report source has been corrected to include foreign and healthcare professional.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block h11 (investigation results): the returned spy ds controller was analyzed.A visual inspection revealed wear and tear on the top cover and front panel.During functional testing, the controller passed all evaluations and exhibited normal device characteristics.No other device problem was noted.Product analysis could not confirm the reported issue of poor-quality imaging.Since the investigation did not reveal any damage or malfunction related to the reported event, a review and analysis of all available information indicated that the most probable cause is classified as no problem detected.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number: 3005099803-2025-02681 for the spyscope ds ii access & delivery catheter and 3005099803-2025-02683 for the spy ds controller.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter and a spy ds controller were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the ercp with poc and ehl, the spyglass ds direct visualization system malfunctioned.Attempts to connect the spyscope to the system were unsuccessful, as the light source failed to activate.Despite checking connections and rebooting the system, the issue persisted, preventing the procedure from proceeding.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.

• Brand Name: SPYGLASS DS
• Common Device Name: LED LIGHT SOURCE
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22229397
• Report Number: 3005099803-2025-02683
• Device Sequence Number: 12979403
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: (01)08714729874348(11)230328(10)2308700037
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142922
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 4665
• Device Lot Number: 2308700037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown