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	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to the spy ds controller used together with the two spyscope ds ii during the same procedure.It was reported to boston scientific corporation that a spy ds controller and the two spyscope ds ii were used during a cholangioscopy procedure performed for the treatment of stricture on an unknown date.During the procedure, the spyscope ds ii did not display an image.A second spyscope ds ii was then used, but the image still failed to appear.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 b3: approximated based on the date the manufacturer became aware of the event.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h2: additional information block b5 (describe event or problem) correction to block b3 (date of event) correction block d2b: subsequent product codes kqm, ntn correction to block d4 (lot number and serial number) correction to block e1 (initial reporter zip/post code) based on the available information, the investigation concluded that the reported event of controller poor quality image could not be confirmed.Without a product returned, no product analysis could be conducted.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.The device was not returned; therefore, a technical analysis could not be performed.Based on the available information, the most probable root cause of the reported event is unable to exclude device problem.
Event or Problem Description
Note: this report pertains to the spy ds controller used together with the two spyscope ds ii during the same procedure.It was reported to boston scientific corporation that a spy ds controller and the two spyscope ds ii were used during a cholangioscopy procedure performed for the treatment of stricture on an unknown date.During the procedure, the spyscope ds ii did not display an image.A second spyscope ds ii was then used, but the image still failed to appear.The procedure was not completed due to this event.There were no reported patient complications as a result of this event.*additional information received on (b)(6) 2026* the cholangioscopy procedure took place on (b)(6) 2026.Both scopes were tested with another spy ds controller and functioned as intended.

• 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: 24247296
• Report Number: 3005099803-2026-00430
• Device Sequence Number: 15867528
• Product Code: FBN
• UDI-Device Identifier: 08714729874348
• UDI-Public: (01)08714729874348
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/04/2026

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: 1515200071
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 06/01/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown