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

Model Number	M00546650
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.
Event or Problem Description
Note: this report pertains to one of 2 devices used during the same procedure.Refer to manufacturer report number for the first device, spy ds controller, and 3005099803-2025-06270 for the for the second device, spyscope ds ii.It was reported to boston scientific that a spyscope ds controller was used with a spyscope ds ii in an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the procedure, before the scope was inserted in the patient, the spy ds controller was reported to not be working properly.The controller powered up, but the lamp would not turn on.The spyscope ds ii could not be used due to lack of visualization.Further troubleshooting determined that there was faulty video cable.The procedure was unable to be completed as a result of this event.Double pigtail stents were placed until patient can be rescheduled for an ercp.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code f1001 captures the reportable event of absence of treatment.Investigation results summary: the spy ds controller was returned for analysis.A technical analysis identified the interface board from the light engine is not producing a signal for the camera board.Therefore, the reported allegation of cable problems in this complaint is 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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.A risk review was completed and confirmed that the event of cabling problems with the subsequent event of cancelled rescheduled post sedation or sedation unknown were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure.The board damaged could have affected the device performance and its integrity leading to the events of cable controller problems and subsequent event of cancelled rescheduled post sedation or sedation unknown experienced by the customer.Since an expected or random component failure was identified without any design or manufacturing issue, the conclusion code of cause traced to component failure is selected for the complaint.
Event or Problem Description
Note: this report pertains to one of 2 devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-06263 for the first device, spy ds controller, and 3005099803-2025-06270 for the for the second device, spyscope ds ii.It was reported to boston scientific that a spyscope ds controller was used with a spyscope ds ii in an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the procedure, before the scope was inserted in the patient, the spy ds controller was reported to not be working properly.The controller powered up, but the lamp would not turn on.The spyscope ds ii could not be used due to lack of visualization.Further troubleshooting determined that there was a faulty video cable.The procedure was unable to be completed as a result of this event.Double pigtail stents were placed until patient can be rescheduled for an ercp.No patient complications were reported as a result of the 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23638255
• Report Number: 3005099803-2025-06263
• Device Sequence Number: 13076243
• Product Code: NTN
• UDI-Device Identifier: 08714729874348
• UDI-Public: (01)08714729874348(11)230216(10)2304700042
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 2304700042
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown