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

Model Number	M0067913500
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lithovue flexscope stopped deflecting and the procedure was cancelled due to this event.
Additional Manufacturer Narrative
Block e1: initial reporter address is(b)(6).Reported here as address exceeded character limit for designated field.Block h6: impact code f1001: is being used to capture the reportable issue of aborted/cancelled procedure.
Additional Manufacturer Narrative
Block e1: initial reporter address is(b)(6); reported here as address exceeded character limit for designated field.Block h6: impact code f1001: is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: the device was returned for analysis, and a media inspection of photo was performed.It was noted that the photo did not show information relevant to reported problem.During functional testing of the device, it was identified that there was no articulation on the up and directions defects were found on the articulation wire stretching on the circular articulating mechanism during visual and x ray inspection caused by the corroded bowden ferrule.The device can display a clear live image.A media inspection was performed but the provided picture shows the packaging and not the deflection problem.A device history record (dhr) review confirms the device met all manufacturing specifications.Based on the investigation and analysis results, a conclusion code of cause traced to component failure meaning expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that the lithovue flexscope stopped deflecting and 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: 23012768
• Report Number: 2124215-2025-61688
• Device Sequence Number: 10038676
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: (01)08714729874805(17)260221(10)33483649
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/13/2026

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 Expiration Date: 02/21/2026
• Device Model Number: M0067913500
• Device Catalogue Number: M0067913500
• Device Lot Number: 0033483649
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Age: 54 YR
• Patient Sex: Female