MAUDE Adverse Event Report: Micro-Tech (Nanjing) Co.,Ltd. DuraClip(TM) Repositionable Hemostasis Clip; Hemostatic Metal Clip For The Gi Tract

Catalog Number	DC0235
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the clip deployment malfunctioned and the clip did not catch tissue.The original intended procedure was egd (endo) esophagogastroduodenoscopy w/control of bleeding any type.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not applicable.
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 informaiton for investigation.We will fill a follow-up report when this incident investigation is done.

• Brand Name: DuraClip(TM) Repositionable Hemostasis Clip
• Common Device Name: Hemostatic Metal Clip For The Gi Tract
• 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, ind; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 50877509
• Report Number: 3004837686-2026-00011
• Device Sequence Number: 18498233
• Product Code: PKL
• UDI-Device Identifier: 16932619740019
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161463
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Catalogue Number: DC0235
• Device Lot Number: M251115M231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2025
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 154 LB
• Patient Race: White