MAUDE Adverse Event Report: OTU MEDICAL INC. APTRA; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	BDSD01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon plugging in then turning on box, logos and time showed on screen but no image appeared; we unplugged and re-plugged and go the same result.We opened another scope and it worked without issue, determining the first scope was defective.

• Brand Name: APTRA
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OTU MEDICAL INC.; 2847a whipple rd.; union city CA 94587
• MDR Report Key: 23802625
• Report Number: 23802625
• Device Sequence Number: 18063890
• Product Code: FGB
• UDI-Device Identifier: 00850023925022
• UDI-Public: (01)00850023925022(17)271124(10)BMIYTU05
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/24/2025
• Report Date (Section F): 11/24/2025

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: BDSD01
• Device Lot Number: BMIYTU05
• 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: 12/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 11/24/2025