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

Model Number	URORD101
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope subject of the reported event was returned to the supplier for evaluation.Upon evaluation, it was discovered that there was wrinkling at the end of the cable of the scope.This caused the distal end of the scope to get caught in between distal cap and insertion tube opening, subsequently causing the reported event.The cause of the observed damage could not be determined.A 1-year complaint review indicated this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, the distal end of their uretero1 reverse deflection disposable ureteroscope became obstructed.The procedure was completed successfully using a different scope.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: 23968918
• Report Number: 3008776287-2026-00008
• Device Sequence Number: 7946256
• Product Code: FGB
• UDI-Device Identifier: 00724995209179
• UDI-Public: (01)00724995209179(11)240326(17)270326(10)BSLC5983
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/05/2026

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: URORD101
• Device Catalogue Number: URORD101
• Device Lot Number: (10)BSLC5983
• 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: 06/04/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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