MAUDE Adverse Event Report: BLACK DIAMOND VIDEO, INC. URETERO1; URETEROSCOPE

Model Number	UROSD101
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process.The device had been returned for evaluation.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, the screen to their uretero1 standard deflection disposable ureteroscope was showing lines and flickering.The procedure was completed successfully using a different ureteroscope.No report of injury.

• Brand Name: URETERO1
• Common Device Name: URETEROSCOPE
• Manufacturer (Section D): BLACK DIAMOND VIDEO, INC.; 503 canal blvd.; richmond CA 94804
• Manufacturer (Section G): BLACK DIAMOND VIDEO, INC.; 503 canal blvd.; richmond CA 94804
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24964568
• Report Number: 3008776287-2026-00122
• Device Sequence Number: 14664993
• Product Code: FGB
• UDI-Device Identifier: 00724995209162
• UDI-Public: (01)00724995209162(11)240425(17)270425(10)BSLC6323
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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 Model Number: UROSD101
• Device Catalogue Number: UROSD101
• Device Lot Number: (10)BSLC6323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 04/25/2024
• 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
• Patient Sex: Unknown