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

Model Number	M0067913500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During common bile duct exploration, surgeon states needing a new lithovue.States "it broke, we need a new one".New supply obtained.Item saved & sent to materials.No harm to pt.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23036893
• Report Number: 23036893
• Device Sequence Number: 9181625
• Product Code: FGB
• UDI-Device Identifier: 08714729874805
• UDI-Public: (01)08714729874805
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025
• Report Date (Section F): 09/08/2025

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: M0067913500
• Device Catalogue Number: M0067913500
• Device Lot Number: 40337302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/08/2025