MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LITHOVUE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M0067913500
Medical Device Problem Codes	No Display/Image (1183); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: impact code f1001: is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported that during procedure, lithovue scope had a "hardware malfunction" user message appeared on the screen.The procedure was cancelled due to this event.
Additional Manufacturer Narrative
Block h6: impact code f1001: is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: upon receipt of the device at our quality assurance laboratory, the device was thoroughly analyzed.Functional examination noted that the device had full articulation in both directions.Visual examination showed no defects to the distal tip, shaft, or pcba were observed.Additionally, no leak was identified, no defects and the device displayed a live, clear image.The reported event was no confirmed.The device history record (dhr) was reviewed and indicated that the device met all manufacturing specifications.Based on the information available, following a comprehensive evaluation, no device defects were identified that could contribute to the reported event.The device is fully functional and successfully passed all analytical tests and inspections.Based on the gathered data and product analysis, the investigation has been concluded with the code no problem detected, indicating the reported issue could not be confirmed.No escalation is required.
Event or Problem Description
It was reported that during procedure, lithovue scope had a "hardware malfunction" user message appeared on the screen.The procedure was cancelled due to this event.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE 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 IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22683329
• Report Number: 2124215-2025-52436
• Device Sequence Number: 9565806
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: (01)08714729874805(17)260321(10)33679991
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K153049
• 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): 01/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2026
• Device Model Number: M0067913500
• Device Catalogue Number: M0067913500
• Device Lot Number: 0033679991
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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