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

Model Number	M00546610
Medical Device Problem Codes	Device-Device Incompatibility (2919); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
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
It was reported to boston scientific corporation that a spyscope ds ii device was intended for use during a biliary duct observation procedure on (b)(6) 2026, in the biliary tract.It was reported that the image disappeared during the procedure.Attempts were made to reconnect the spyscope to the controller; however, despite these efforts, the procedure could not be completed and had to be rescheduled.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 h2 (device analysis) the returned device was analyzed and the reported clinical observation of loss of visualization could not be confirmed.However, a leak and internal damage to the scope was discovered.During the visual inspection of the returned device, no visual damage was observed.The camera tip showed evidence of the hydrophobic coating applied over the back of the camera assembly during manufacturing.During the image test, the device was connected to the controller and displayed image as expected.During the functional inspection, it was seen that the tip of the camera articulates without any issues, the image is not lost when articulating the tip.The reported visualization complaint was not confirmed.A leak test was performed, and water was observed to be leaking from the breakout region of the scope.Destructive testing and microscopic imaging were conducted and a tear to the pebax, a flexible material located at the tip of the scope, was discovered.This tear allowed fluid to enter the scope's optics lumen.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A risk review was completed and confirmed that the event of 'cancelled/rescheduled - post sedation/sedation unknown' 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.With all available information, the reported loss of visualization will be addressed by the conclusion code 'no problem detected' as visualization functioned as intended during the returned device analysis.The damage to the pebax region and resulting leak will be addressed as 'cause traced to component failure'.'cancelled/rescheduled - post sedation/sedation unknown' will be addressed as 'adverse event related to procedure' since the event was not completed due to the conditions faced during the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a spyscope ds ii device was intended for use during a biliary duct observation procedure on (b)(6) 2026, in the biliary tract.It was reported that the image disappeared during the procedure.Attempts were made to reconnect the spyscope to the controller; however, despite these efforts, the procedure could not be completed and had to be rescheduled.No patient complications were reported as a result of this event.

• Brand Name: SPYSCOPE? DS II
• Common Device Name: CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24834969
• Report Number: 3005099803-2026-01304
• Device Sequence Number: 10305847
• Product Code: FBN
• UDI-Device Identifier: 08714729965404
• UDI-Public: (01)08714729965404(17)271125(10)40409056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/04/2026

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: M00546610
• Device Catalogue Number: M00546610
• Device Lot Number: 0040409056
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/04/2026
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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