MAUDE Adverse Event Report: OTU MEDICAL INC. 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	Insufficient Information (4580)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Event title: confidential describe the event or problem: while performing the procedure the physician was using a rigid ureteroscope, and he felt it break.We opened a single use digital flexible ureteroscope and while using this scope again, he commented that he felt it broke.It was pulled out of the patient and examined.The scrub tech asked the physician if a piece could have been left behind in the patient.He said if it did it would be too small to be seen.What was the original intended procedure? retrograde renoscopic stone extraction with laser lithotripsy and stent exchange what problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: 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 CA 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, ca 94587; union city, CA 94587 ; 4084619801
• MDR Report Key: 19988418
• Report Number: 3013992977-2024-00001
• Device Sequence Number: 20573946
• Product Code: FGB
• UDI-Device Identifier: 00850023925022
• UDI-Public: (01)00850023925022(17)260721(10)BMHUTU01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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 Expiration Date: 07/21/2026
• Device Model Number: BDSD01
• Device Catalogue Number: BDSD01
• Device Lot Number: BMHUTU01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 65 KG