MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE

Model Number	URORD101
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scope is being returned to the supplier for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a procedure there was intermittent video interference to their uretero1 reverse deflection disposable ureteroscope.There was a delay in the procedure to switch to a different scope.The procedure was completed successfully.
Additional Manufacturer Narrative
The ureteroscope was returned to the supplier for evaluation, however, the exact cause of the reported event could not be determined.No issues with the function or operation of the ureteroscope were noted.The customer was provided with in-service training on the use and operation of the ureteroscope prior to the reported event.No additional issues have been reported.

• Brand Name: URETERO1 REVERSE DEFLECTION DISPOSABLE URETEROSCOPE
• Common Device Name: DISPOSABLE URETEROSCOPE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 18918441
• Report Number: 1528319-2024-00018
• Device Sequence Number: 7683110
• Product Code: FGB
• UDI-Device Identifier: 00724995209179
• UDI-Public: 00724995209179
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 03/15/2024

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: BSLC1935
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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