MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. SINGLE-USE VIDEO PANCREATICOBILIARY SCOPE

Catalog Number	CDS11007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After micro-tech received this incident.We reviewed the manufacturing documents from the device history record and found no abnormalities that would contribute to this issue.We are trying to get more information for investigation.We will fill a follow-up report when this incident investigation is done.
Event or Problem Description
It was reported that physician attempted to move dial on scope and stated it broke.
Additional Manufacturer Narrative
1.The defective products were not sent back to micro-tech.The customer feedback is as follows: physician attempted to move dial on scope and stated it broke.The customer feedback the big directional wheel on the eye-max scope would not engage/operate.This would not operate at all and could not allow for duct insertion.The surgery did not cause harm to the patient, but it did delay the surgical time to some extent.No relevant pictures or videos have been provided.2.Analysis analyze from the following aspects: a.Dhr investigation: according to the batch information, investigate the dhr records.All raw materials are qualified and put into storage.During the manufacturing process, inspection process and packaging process, there is no abnormality, and the incoming and outgoing products have all been inspected and qualified.B.Dhr investigation: according to the batch information, investigate the dhr records.All raw materials are qualified and put into storage.During the manufacturing process, inspection process and packaging process, there is no abnormality, and the incoming and outgoing products have all been inspected and qualified.C.Packaging and transportation investigation: the finished product packaging is packed and fixed in the special packaging suction plastic box, and the packaging and transportation method has been packaged verified.The existing packaging and transportation plan meets the product performance requirements, so the probability of packaging and transportation leading to customer complaints.3.Conclusion based on the above investigation and analysis.Since the product cannot be returned to micro-tech for further analysis, the root cause of the traction wire breakage cannot be determined for the time being.Through the above investigation and analysis, combined with the risk analysis, the probability of occurrence is rare, the benefit-risk has not changed, and the risk is acceptable.Therefore, we will continue to pay attention and not take corrective preventive measures.

• Brand Name: SINGLE-USE VIDEO PANCREATICOBILIARY SCOPE
• Common Device Name: SINGLE-USE VIDEO PANCREATICOBILIARY SCOPE
• Manufacturer (Section D): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 22563368
• Report Number: 3004837686-2025-00008
• Device Sequence Number: 21152951
• Product Code: NTN
• UDI-Device Identifier: 06932503563680
• UDI-Public: (01)06932503563680(17)261124(10)M241125703
• Combination Product (Y/N): N
• PMA/510(K) Number: K221784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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
• Device Catalogue Number: CDS11007
• Device Lot Number: M241125703
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/19/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White