MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LithoVue? Elite; Ureteroscope and Accessories, Flexible/Rigid

Model Number	M0067941000
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.
Event or Problem Description
It was reported that, during a flexible ureteroscopy procedure, the physician found that the lithovue non-pressure ureteroscope shows problem with visual.Initial optics in the ureter were fine; however, once the scope was deflected into the kidney and a laser fiber was introduced, the monitor began flashing black and white in a strobe light.The problem persisted throughout the case.The physician was unable to visualize the kidney stone and aborted the procedure, placing a stent instead.The patient is expected to fully recover but will require a second surgery to complete stone treatment.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.Block h11: correction to field block h1: type of reportable event.
Event or Problem Description
It was reported that, during a flexible ureteroscopy procedure, the physician found that the lithovue non-pressure ureteroscope shows problem with visual.Initial optics in the ureter were fine; however, once the scope was deflected into the kidney and a laser fiber was introduced, the monitor began flashing black and white in a strobe light.The problem persisted throughout the case.The physician was unable to visualize the kidney stone and aborted the procedure, placing a stent instead.The patient is expected to fully recover but will require a second surgery to complete stone treatment.

• 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
• 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: 23584555
• Report Number: 2124215-2025-84173
• Device Sequence Number: 18491345
• Product Code: FGB
• UDI-Device Identifier: 08714729997351
• UDI-Public: (01)08714729997351(17)260828(10)37321050
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K233645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 08/28/2026
• Device Model Number: M0067941000
• Device Catalogue Number: M0067941000
• Device Lot Number: 0037321050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 08/26/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/31/2025; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown