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

Model Number	M00546650
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a spyglass ds controller and two spyscope ds ii were attempted for use during an endoscopic retrograde cholangiopancreatography (ercp) and cholangioscopy procedure on (b)(6) 2026.During the procedure, the surgical team attempted to connect the spyscope to the console and it was not recognized.It was indicated that there was difficulty plugging in the scope.Troubleshooting tasks included switching off the entire system and unplugging the scope before retrying.The problem did not resolve.Another spyscope was attempted for use however, the result was the same.The procedure was unable to be completed.No patient complications were reported as a result of the event.Both scopes were tested with a second controller following the procedure, both scopes functioned as intended.
Additional Manufacturer Narrative
Block h6: imdrf code f001 captures the reportable event of absence of treatment.D2b: subsequent pro codes kqm ntn.Investigation result summary the spy ds controller was not returned for analysis as it was disposed.Therefore, a technical analysis could not be performed and the reported events of device connection issue and cancelled/rescheduled post sedation/sedation unknown could not be confirmed.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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.There is no evidence the device was improperly used per the ifu.A risk review was completed and confirmed that the events of device connection issue and cancelled/rescheduled post sedation/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 not established as the most probable cause of the cancelled procedure cannot be established due to lack of evidence.The probable cause of the device connection issue has been assigned the conclusion code of unable to exclude device problem since the investigation findings cannot confirm the presence or absence of the reported problem with the device, and the device was not received for evaluation.

• 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: 24597380
• Report Number: 3005099803-2026-00945
• Device Sequence Number: 21222704
• Product Code: FBN
• UDI-Device Identifier: 08714729874348
• UDI-Public: (01)08714729874348(11)160406(10)1609700002
• 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): 07/07/2026

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: 1609700002
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 04/06/2016
• 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