MAUDE Adverse Event Report: Transmed (China) Co., Ltd. DuraClip(TM) Repositionable Hemostasis Clip; Hemostatic Metal Clip For The Gi Tract

Model Number	DC0235
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Deployment malfunctioned; did not catch tissue.

• Brand Name: DuraClip(TM) Repositionable Hemostasis Clip
• Common Device Name: Hemostatic Metal Clip For The Gi Tract
• Manufacturer (Section D): Transmed (China) Co., Ltd.; 5350 w hoge drive; bloomington IN 47403
• MDR Report Key: 50801601
• Report Number: 50801601
• Device Sequence Number: 20972826
• Product Code: PKL
• UDI-Device Identifier: 16932619740019
• UDI-Public: (01)16932619740019(11)251115(17)281114(10)M251115M231
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2026
• Report Date (Section F): 08/31/2026

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: DC0235
• Device Catalogue Number: DC0235
• Device Lot Number: M251115M231
• 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: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• 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 Sex: Female
• Patient Weight: 154 LB
• Date Report Sent to FDA: 08/31/2026