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

Model Number	M00546780
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11(investigation results): the device was returned and visually examined.It was noted that the suction luer was detached upon receipt.During imaging evaluation, the device was connected to the controller and produced an image as expected.Functional testing confirmed that the camera tip articulated properly, with no loss of image during articulation.No residue was observed in the handles breakout area.A leak test could not be completed due to the detached suction/aspiration luer.The reported issue related to visualization was not confirmed.Therefore, this investigation has been assigned the most probable conclusion code of device problem excluded.This determination was made because the device was thoroughly inspected for any damage or condition that might have contributed to the reported visualization problem; however, no such damage was identified.The device functioned as intended and successfully passed all applicable tests, displaying proper image quality.Cancelled/rescheduled - post sedation/sedation unknown and prolonged episode of care will be addressed as adverse event related to procedure since the event was not completed due to the complications faced during the procedure.
Event or Problem Description
Note: this report pertains to one of two spy discover catheters used during the same procedure.It was reported to boston scientific corporation that two spy discover catheters were attempted for use in the cystic duct with common bile duct during a laparoscopic cholecystectomy procedure on (b)(6) 2025, for the treatment of choledocholithiasis.During the procedure, the visualization flickered and then changed to the loading screen approximately ten minutes after the fluidics pump was activated for irrigation.Attempts to restore visualization by unplugging and reconnecting the device were unsuccessful.They attempted to use a second spy discover catheter, which presented with the same malfunction.A balloon sweep was then attempted but failed to remove the stone.After a delay of approximately 30 minutes, the laparoscopic cholecystectomy procedure was discontinued.The patient was then sent interventional radiology (ir) for a percutaneous transhepatic cholangiography (ptc).No patient complications were reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two spy discover catheters used during the same patient and the same procedure.It was reported to boston scientific corporation that two spy discover catheters were attempted for use in the cystic duct with common bile duct during a laparoscopic cholecystectomy procedure on (b)(6) 2025, for the treatment of choledocholithiasis.During the procedure, the visualization flickered and then changed to the loading screen approximately ten minutes after the fluidics pump was activated for irrigation.Attempts to restore visualization by unplugging and reconnecting the device were unsuccessful.They attempted to use a second spy discover catheter, which presented with the same malfunction.A balloon sweep was then attempted but failed to remove the stone.After a delay of approximately 30 minutes, the laparoscopic cholecystectomy procedure was discontinued.The patient was then sent interventional radiology (ir) for a percutaneous transhepatic cholangiography (ptc).No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.

• Brand Name: SPYGLASS? DISCOVER
• 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: 24184297
• Report Number: 3005099803-2026-00301
• Device Sequence Number: 10016541
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: (01)08714729994183(17)270815(10)40363331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: M00546780
• Device Catalogue Number: M00546780
• Device Lot Number: 0040363331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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