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

Model Number	URORD101
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The uretero1 reverse deflection disposable ureteroscope subject of the reported event is being returned for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via medwatch # (b)(4) that, "uretero1, disposable flexible ureteroscope image gets cut off, intermittently lost and keeps cutting out or flickering.Or team found a crack at the base of the scope at the end of the procedure.The sales representative for the product was contacted and the plan will be to return the scope for inspection.".
Additional Manufacturer Narrative
Steris incorrectly filed the reported event under 300776287-2025-00007.The investigation for the event has been correctly filed in mdr 1528319-2025-00081.

• 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 ; 4403927453
• MDR Report Key: 22612789
• Report Number: 3008776287-2025-00007
• Device Sequence Number: 5418817
• Product Code: FGB
• UDI-Device Identifier: 00724995209179
• UDI-Public: (01)00724995209179
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K231878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: URORD101
• Device Catalogue Number: URORD101
• Device Lot Number: (10)BSLC4884
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown