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	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Plugged scope in and there was no picture, obtained a new scope and obtained an image, proceeded with the procedure.

• 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: 24980101
• Report Number: 24980101
• Device Sequence Number: 9698844
• Product Code: FGB
• UDI-Device Identifier: 00850023925022
• UDI-Public: (01)00850023925022(17)280702(10)BMJUTU01
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026
• Report Date (Section F): 04/20/2026

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 Model Number: BDSD01
• Device Lot Number: BMJUTU01
• 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: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Date Report Sent to FDA: 04/20/2026