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

Model Number	M00546780
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that spyscope ds ii was used during a robotic cholecystectomy with common bile duct exploration on (b)(6) 2025.There was no visualization when the scope was plugged in.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 h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.

• 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; 780 brookside drive; spencer 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21696376
• Report Number: 3005099803-2025-01240
• Device Sequence Number: 8773904
• Product Code: FBN
• UDI-Device Identifier: 08714729994183
• UDI-Public: 08714729994183
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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
• 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: 03/04/2025
• Initial Report FDA Received Date: 03/26/2025
• 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: Prefer Not To Disclose