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

Model Number	URORD101
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure a distorted image appeared once their uretero1 single-use digital flexible ureteroscope connected to the monitor.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.Evaluation determined the shaft was bent at the distal tip.This is where the connectivity failed.The source of the excess force that caused the shaft to become bent could not be determined.No additional issues have been reported.Udi data clarification - a follow-up mdr will be submitted with the device manufacture date and device expiration date.

• Brand Name: URETERO1
• Common Device Name: URETERO1 STANDARD DEFLECTION DISPOSABLE 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: 23973424
• Report Number: 3008776287-2026-00018
• Device Sequence Number: 9082033
• Product Code: FGB
• UDI-Device Identifier: 00724995209162
• UDI-Public: (01)00724995209162(11)230512(17)260512(10)BSLC1941
• 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): 01/06/2026

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 Expiration Date: 05/12/2026
• Device Model Number: URORD101
• Device Catalogue Number: URORD101
• Device Lot Number: (10)BSLC1941
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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