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	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent a cystoscopy with ureteral stent exchange, ureteroscopy with holmium lithotripsy, right ureteral stone removal, right renal stone removal, cystolitholapaxy with laser.During the procedure surgeon requested to utilize a lithovue device.After plugging in the disposable it functioned appropriately for approximately 30 seconds, before failing to produce an image.Device was reset and use attempted again without success.A second disposable lithovue was obtained and utilized by surgeon without issue.The malfunctioning device was removed from field at end of case and placed in a red bag along with its original packaging.Ref: m0067913500, lot: 40424407, exp:01/15/2028.

• Brand Name: LITHOVUE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 24965239
• Report Number: 24965239
• Device Sequence Number: 16066129
• 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): 04/21/2026
• Report Date (Section F): 04/21/2026

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: Other
• Device Model Number: M0067913500
• Device Catalogue Number: M0067913500
• Device Lot Number: 40424407
• 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: 04/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/21/2026