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

Model Number	M0067941000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ureteroscopes were pulled for an ureteroscopy case.Four ureteroscopes were tried, but none of them worked properly.The scopes either failed to connect, had faulty channels, or displayed error codes.The operating room team communicated directly with the rep, but they still couldn't get the scopes to function.It was decided to pull all ureteroscopes with the same lot numbers.A total of 3 more ureteroscopes were pulled from the shelf.Email communications continued with the rep thru this entire process.A total of 7 scopes problematic.

• Brand Name: LITHOVUE¿ ELITE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23424674
• Report Number: 23424674
• Device Sequence Number: 21295685
• Product Code: FGB
• UDI-Device Identifier: 08714729997351
• UDI-Public: (01)08714729997351(17)260813(10)37202156
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025
• Report Date (Section F): 10/15/2025

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: M0067941000
• Device Catalogue Number: M0067941000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• 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: 10/15/2025