MAUDE Adverse Event Report: TRANSMED (CHINA) CO., LTD. DURACLIP(TM) REPOSITIONABLE HEMOSTASIS CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	DC0235W
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tissue clip misfired.

• Brand Name: DURACLIP(TM) REPOSITIONABLE HEMOSTASIS CLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): TRANSMED (CHINA) CO., LTD.; 2855 boardwalk drive; ann arbor MI 48104
• MDR Report Key: 21263101
• Report Number: 21263101
• Device Sequence Number: 11831334
• Product Code: PKL
• UDI-Device Identifier: 16932619740033
• UDI-Public: (01)16932619740033(17)250423(10)M220424592
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2025
• Report Date (Section F): 01/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: DC0235W
• Device Catalogue Number: DC0235W
• Device Lot Number: M220424592
• 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: 01/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Date Report Sent to FDA: 01/23/2025