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

Model Number	M0067940000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure team attempted to use the lithovue elite -single use digital flexible ureteroscope.Sensor for water pressure stopped working mid case.Could not be corrected.Scope and box saved.Boston scientific: ref# m006794000, lot# 37817017, exp:10/28/26.Gtin# (b)(4).

• Brand Name: LITHOVUE¿ ELITE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 25407882
• Report Number: 25407882
• Device Sequence Number: 21407969
• Product Code: FGB
• UDI-Device Identifier: 08714729997337
• UDI-Public: (01)08714729997337
• 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): 05/29/2026
• Report Date (Section F): 05/29/2026

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 Model Number: M0067940000
• Device Catalogue Number: M0067940000
• Device Lot Number: 37817017
• 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: 06/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/29/2026