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

Model Number	M0068010000
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code f1001 captures the reportable event of absent of treatment.
Event or Problem Description
It was reported that during preparation, the switch on the screen of the touch pc (b)(4) will not work.The procedure was rescheduled due to this event.There were no patient complications.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.

• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25191453
• Report Number: 2124215-2026-26188
• Device Sequence Number: 18725442
• Product Code: FGB
• UDI-Device Identifier: 08714729974789
• UDI-Public: (01)08714729974789(10)LV04255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2026

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: M0068010000
• Device Catalogue Number: M0068010000
• Device Lot Number: LV04255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 07/29/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 07/31/2026; 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male