MAUDE Adverse Event Report: US ENDOSCOPY URETERO1; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	URORD101
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Defective uretero1 flexible ureteroscope.Doctor was using the uretero1flexible ureteroscope and had been worked fine.But suddenly, the image was lost and the screen said, "scope not detected." we changed to another monitor, but same message showed.The procedure was almost finished at that time; he didn't need another uretero1.The patient has no injury.

• Brand Name: URETERO1
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 22530184
• Report Number: 22530184
• Device Sequence Number: 20685356
• Product Code: FGB
• UDI-Device Identifier: 00724995209179
• UDI-Public: (01)00724995209179
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025
• Report Date (Section F): 07/01/2025

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: BSLC4884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Date Report Sent to FDA: 07/01/2025