MAUDE Adverse Event Report: US ENDOSCOPY URETERO1; URETERO1 REVERSE DEFLECTION DISPOSABLE 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
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
The initial mdr for this event was incorrectly filed under 300776287-2025-00007.Steris is submitting this mdr under the correct product registration information and should be noted the initial mdr filed under 300776287-2025-00007 was submitted within the 30-day reporting criteria requirement.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.
Additional Manufacturer Narrative
The uretero1 reverse deflection disposable ureteroscope subject of the reported event was returned for evaluation.Evaluation results found damage to the device and exposed wiring.The wire shaft also appeared to be bent exposing wires underneath.The source of the observed damage could not be determined.The device history record was reviewed and confirmed the device was manufactured to specification; no abnormalities were noted.No additional issues have been reported.

• Brand Name: URETERO1
• Common Device Name: URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4405197842
• MDR Report Key: 22743499
• Report Number: 1528319-2025-00081
• Device Sequence Number: 8507017
• Product Code: FGB
• UDI-Device Identifier: 00724995209179
• UDI-Public: (01)00724995209179(11)231212(17)261212(10)BSLC4884
• 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): 08/07/2025

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
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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