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

Model Number	BDSD01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Urolithiasis (4861)
Date of Event	11/24/2025
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 SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OTU MEDICAL INC.; 2847a whipple rd, union city,; union 94587
• Manufacturer (Section G): NINGBO WISE OPTOMECH TECHNOLOGY CORPORATION; 2f, building 12, sankari park,; 688jinda road,yinzhou district; ningbo, zhejiang 31510 0; CH 315100
• Manufacturer Contact: anna luo ; 2847a whipple rd; union city 94587 ; 4084619801
• MDR Report Key: 24128833
• Report Number: 3013992977-2025-00001
• Device Sequence Number: 5532279
• Product Code: FGB
• UDI-Device Identifier: 00850023925022
• UDI-Public: (01)00850023925022(17)271124(10)BMIYTU05
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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 Catalogue Number: BDSD01
• Device Lot Number: BMIYTU05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 4900420000-2025-8021
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 84 KG