MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SpyGlass DS; choledochoscope and accessories, flexible/rigid

Model Number	M00546650
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a spyscope device was intended for use with a spy controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2026.During the procedure, the physician initially had normal visualization.However, after some time, the image was suddenly lost completely.Multiple attempts were made to restore the image by disconnecting and reconnecting the system components; however, the issue persisted and visualization was not recovered.The procedure was unable to be completed as a result of this event, and the patient will be rescheduled for a repeat procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block d2b: subsequent pro codes kqm, ntn.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a spyscope device was intended for use with a spy controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6)2026.During the procedure, the physician initially had normal visualization.However, after some time, the image was suddenly lost completely.Multiple attempts were made to restore the image by disconnecting and reconnecting the system components; however, the issue persisted and visualization was not recovered.The procedure was unable to be completed as a result of this event, and the patient will be rescheduled for a repeat procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of absence of treatment.Block d2b: subsequent pro codes kqm, ntn.Block h2: based on the available information, the root cause of the reported loss of visualization, which resulted in the device being unable to be used to continue the procedure as intended, cannot be established.The product was not returned for analysis; therefore, the reported event could not be confirmed, and no product analysis could be conducted to identify a potential device defect.The device has not been returned for analysis.Therefore, the root cause of the reported loss of visualization cannot be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A similar complaint review was completed.There were no emerging trends identified that warrant further action.A risk review was completed and confirmed that the event of absence of treatment was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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, the most probable cause of the reported loss of visualization cannot be established due to lack of objective evidence.The product was not returned for analysis, preventing evaluation of the device for a potential defect.Therefore, without proper evaluation of the device, the most probable cause that contributed to the reported event remains unknown.

• 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 ; +1(914)571-6918
• MDR Report Key: 25429704
• Report Number: 3005099803-2026-02352
• Device Sequence Number: 10284911
• Product Code: FBN
• UDI-Device Identifier: 08714729874348
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K183636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 1610600531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 04/15/2016
• 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